BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 2003352 · Received March 1, 2011

    Report

    Report Number
    3008500478-2011-00052
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2011- A PRODUCT RISK ASSESSMENT (PRA) WAS INITIATED (B)(4), 2011 FOR CORONARY SINUS CATHETER DISTAL BALLOON BOND FAILURE AND IS APPLICABLE TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(6) 2011 - EVALUATION RESULTS: THE BALLOON WAS VISUALLY INSPECTED UNDER 10X MAGNIFICATION AND THERE ARE NO HOLES OR RUPTURES DETECTED WITH THE BALLOON. COLORED WATER WAS INTRODUCED THROUGH THE BALLOON LUMEN AND THERE IS DELAMINATION OF THE DISTAL BALLOON BOND. VISUALLY THERE ARE NO OTHER DEFECTS DETECTED. WATER WAS INTRODUCED THROUGH ALL BUT THE BALLOON LUMEN AND THE WATER FLOWS FROM WHERE IT SHOULD. THERE ARE NO OTHER DEFECTS DETECTED WITH THIS DEVICE. THESE DEVICES ARE VISUALLY AND FUNCTIONALLY TESTED 100% PRIOR TO PACKAGING. A CORRECTIVE ACTION WAS CREATED BY THE MANUFACTURER TO DETERMINE ROOT CAUSE OF THE DISTAL BALLOON BOND DELAMINATION TREND AND IS APPLICABLE TO THIS EVENT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT 774334 AND THIS DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDOPLEGE BALLOON RUPTURED DURING PREP. THE CUSTOMER TRIED TO PUT FLUID IN THE BALLOON AND IT WOULDN'T FILL AND THERE WAS A LITTLE HOLE. DEVICE WAS SAVED. DEVICE WAS NEVER USED NEVER ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 774334

    Patients

    Seq Age Sex Outcome Treatment
    1