F01P1

Organization name

Front Line Medical Technologies Inc.

SRN

CA-MF-000035504

Manufacturer status

Active

25 warnings recorded — scroll inside the panel to see all entries.

• If resistance or an obstruction is encountered when advancing the device, remove the device and use an alternative means of treatment.

  OTHER

• Do not exceed more than 10 balloon inflation/deflation cycles.

  OTHER

• The balloon should be inflated slowly to avoid over inflation and should be deflated slowly to avoid patient hypotension.

  OTHER

• The patient’s blood pressure should be monitored closely throughout the procedure.

  OTHER

• Once temporary occlusion has been achieved, immediate measures should be taken for definitive care by a surgical team.

  OTHER

• MR UNSAFE

  The COBRA-OS® has not been tested for use with MRI (Magnetic Resonance Imaging). The patient should not receive an MRI exam while using the COBRA-OS®.

• Do not resterilize

  Do not reprocess or re-sterilize which may increase the risk of patient infection and/or affect the functionality of the device.

• Do not re-use

  The COBRA-OS® is a single use medical device for a single patient: as the device is contaminated with patient blood, its use on another patient can lead to blood group cross-reactions or transfer of potential blood borne infections.

• Do not use if package is damaged

  The package and device should be inspected prior to use to verify that no damage has occurred during shipment or storage. If the package or device is damaged, then do not use the device because sterility and/or device functionality may be compromised.

• Do not use past indicated date

  Do not use the device after the expiration date on the label.

• Do not exceed maximum inflation volume (13 mL) and adhere to suggested volumes in Table 1. Over inflation may result in damage to the vessel wall, vessel rupture, balloon rupture, and/or air embolism. - Hand inflation using a 10 mL syringe is recommended to help prevent over inflation of the balloon when using larger volume syringes. - Do not use an inflation device to inflate the balloon, which may cause over inflation.

  OTHER

• The COBRA-OS® must be purged of air, fully deflated, and the stopcock closed prior to inserting through the introducer sheath. Failure to do so may make it difficult to insert/advance the device and/or cause an air embolism if the balloon ruptures.

  OTHER

• The COBRA-OS® must be fully deflated and stopcock closed prior to removing the device. Failure to do so may make it difficult/impossible to remove the device from the introducer sheath and/or vessel.

  OTHER

• When attaching and detaching the syringe, hold on to the stopcock and not the overmolded hub. Holding on to the overmolded hub may cause the stopcock to separate from the device.

  OTHER

• Do not use the COBRA-OS® for dilation of vascular grafts. Balloon rupture and/or damage to the vessel may occur.

  OTHER

• Do not use the COBRA-OS® to perform valvuloplasty or angioplasty.

  OTHER

• In pregnant patients, standard local guidelines for minimizing radiation exposure to the foetus should be used until the baby is delivered.

  OTHER

• If available, use conventional x-ray or fluoroscopy to help confirm the position of the device and assist with balloon inflation and deflation. - Zone markers on the COBRA-OS® may be used to measure and track the depth of the device.

  OTHER

• Use a recommended balloon inflation medium with appropriate concentration and dilution. Do not use air or gas to inflate balloon.

  OTHER

• The COBRA-OS® is intended for temporary occlusion only. Longer term or permanent application of this device will cause major harm and/or death.

  OTHER

• Training and experience in endovascular techniques is recommended for users of the COBRA-OS®.

  OTHER

• Long occlusion times may cause major harm and/or death.

  OTHER

• Do not modify the device or components in any way.

  OTHER

• Care should be taken when using the COBRA-OS® in vessels with anatomic variability or otherwise diseased vessels.

  OTHER

• The device should not be used in the treatment of dissection.

  OTHER

Primary placement in Spain; available across 12 countries total.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• C019009AORTIC OCCLUSION SYSTEMS

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.