CA804120

Organization name

ProstaLund AB

SRN

SE-MF-000004428

Manufacturer status

Active

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

• CW010

  There is a risk for complications if the CoreTherm® Catheter is not handled carefully and correctly. The risk for complications can be minimized by using the product as described in this instruction for use
• CW999

  Exercise care when inserting the CoreTherm® Catheter into the patient’s urethra, otherwise perforation and subsequent infection of the urethra may result. If the CoreTherm® Catheter is incorrectly placed or moves during treatment, or if the Microwave Antenna comes loose, the patient’s external sphincter may overheat, causing temporary or chronic incontinence
• CW009

  The CoreTherm® Catheter is intended for single use only, otherwise cross-patient urinary infection could result. Each CoreTherm® Catheter has a unique catheter serial number (SN), and the software includes a lock which prevents reuse of a catheter. Do not attempt to use a CoreTherm® Catheter for more than one treatment session.
• CW999

  Please make sure to check the balloon with 20 ml of air before inserting it into the patient. While inside the patient’s bladder, inject 20 ml of sterile water slowly in order to prevent rupture of the balloon. Balloon rupture could lead to sliding of the catheter downwards and cause damage on the external sphincter and the urethra
• CW999

  Do not use saline solution when filling the balloon and water reservoir as this may result in increased temperatures due to interaction between the microwaves and the ions.

Primary placement in Sweden; available across 3 countries total.

Trade name

not provided

UDI-DI code

07350081910082

Basic UDI-DI

0735008191CA804X20Q8

Reference / catalog number

CA804120

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

Treatment Catheter for thermotherapy treatment of BPE Duration of use: < 30min Material: Schelin Catheter

Additional information URL

https://coretherm.com/

Clinical sizes

• Short

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

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

• Z12160301EQUIPMENT FOR MICROWAVE PROSTATE THERMOTHERAPY