ACP16-145-20

Organization name

AprioMed AB

SRN

SE-MF-000001013

Manufacturer status

Active

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

• CW999

  Good medical judgement should be exercised in considering biopsy on patients who are receiving anticoagulant therapy or who have bleeding disorders. Use in these patient populations may result in severe bleeding
• CW999

  The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures
• CW999

  If the needle are damaged or bent, do not use. Attempt to correct bent parts may cause breakage. Do not use excessive force against resistance, it may damage or fracture the AprioCore plus and result in materials remaining in the body.
• CW999

  AprioCore plus is intended for use in image-guided procedures only. Verify the device location using imaging techniques after every device adjustment. Do not use AprioCore plus in Magnetic Resonance Imaging (MRI) equipment. The device is magnetic and exposure to MRI may cause unintended device movement
• CW999

  One potential complication of coaxial image-guided biopsy and unintentional activation of biopsy device is inadvertent perforation of adjacent structures. Inadvertent perforation may result in site specific complications which may consist of bleeding, including bleeding from the large artery, hematoma, hemorrhage, infection, pain, cardiac tamponade, pneumothorax, hemoptysis and hemothorax
• CW999

  Precaution 1: The device must be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of core needle biopsy, in particular, those relating to the specific organ being biopsied
• CW999

  Precaution 2: Before use together with other biopsy instruments, check the compatibility in length and gauge together with AprioCore plus (see IFU table 1).
• CW027

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW999

  Precaution 4: After use, the components may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
• CW999

  Precaution 3: Do not test fire AprioCore plus into the air before a procedure. Test fire without support of tissue may cause damage to the needle/cannula tip

Primary placement in Sweden; available across 32 countries total.

Trade name

not provided

UDI-DI code

07350031350159

Basic UDI-DI

73500313510KE

Reference / catalog number

ACP16-145-20

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://apriomed.com/wp-content/uploads/29488.pdf

Clinical sizes

• 14.5 MU10
• 16

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

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

• A0102010101SHEARING BIOPSY NEEDLES