BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 3021949 · Received March 26, 2013

    Report

    Report Number
    3008500478-2013-00411
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 22, 2013
    Report Date
    May 6, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K964248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF THE BALLOON RUPTURE WAS CONFIRMED. THE BALLOON HAD RUPTURED. IT IS NOT KNOWN WHAT CAUSED THE BALLOON TO RUPTURE DURING USE. THE RUPTURE OF THE BALLOON WAS NOT NOTED DURING PREP OF THE DEVICE BEFORE USE. OVER-INFLATION OF THE BALLOON CAN CAUSE THE BALLOON TO RUPTURE. HOWEVER, IN THIS CASE, THERE IS NO INDICATION THAT THE BALLOON WAS OVERINFLATED. SINCE THE ROOT CAUSE OF THE BALLOON RUPTURE IS NOT KNOWN, NO CORRECTIVE ACTION IS DETERMINED NECESSARY AT THIS TIME. MANUFACTURING RECORDS WAS REVIEWED AND THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS DEVICE. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED UPON PRODUCT RETURN FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY AN EDWARDS' SALES REP: "A PROCEDURE WAS PERFORMED ON (B)(6) 2013, THE DR WAS IN CHARGE OF PLACING THE ENDOPLEGE CORONARY SINUS CATHETER. THE DR DID THE USUAL PREPPING OF THE CATHETER. THEY'VE POSITIONED THE PRODUCT USING TEE AND FLUOROSCOPY. DURING THE SURGERY, THEY NOTED THAT THE BALLOON AT THE TIP OF THE ENDOPLEGE CATHETER WAS RUPTURED. THEY REMOVED THE CATHETER AND DECIDED TO USE ANTEGRADE CARDIOPLEGIA ONLY."NO PATIENT INJURY WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123661 ENDOPLEGE CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES EP A10073

    Patients

    Seq Age Sex Outcome Treatment
    1