BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONARY SINUS CATHETER

    MDR report key: 2911689 · Received January 11, 2013

    Report

    Report Number
    3008500478-2013-00363
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 28, 2012
    Report Date
    February 11, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED, ANY MANUFACTURING DEFECT WITH THE DEVICE CANNOT BE ASSESSED. HOWEVER, IT IS LIKELY THAT THE ROOT CAUSE OF THE INTRODUCER LEAKING IS RELATED TO THE ROOT CAUSE ATTRIBUTED TO SIMILAR COMPLAINTS RECEIVED FOR THE LEAKING THAT HAVE BEEN CONFIRMED PER ASSESSMENT BY R&D AND QUALITY ENGINEERING OF THE SIMILAR COMPLAINTS WITH RETURNED DEVICES, THE ROOT CAUSE OF THE LEAKING HAS BEEN DETERMINED TO BE A MATERIAL RELAXATION ISSUE. IT IS NOT KNOWN AT THIS TIME IF THE VALVE LEAKING IS A DESIGN OR A SUPPLIER MANUFACTURING ISSUE. A CAPA HAS BEEN INITIATED FOR THESE COMPLAINTS AND PRODUCT RECALL. 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

    THE PRODUCT WAS NOT RETURNED AND THE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS DEVICE. THEREFORE, A CAPA WAS NOT INITIATED FOR THIS EVENT. THIS INFORMATION WILL BE INCLUDED IN TRENDING AND FUTURE CAPA DETERMINATIONS.

    Description of Event or Problem · 1

    IT WAS PHONED IN BY THE SALES REP THAT THE MD EXPERIENCED SIGNIFICANT LEAKAGE OUT OF THE INTRODUCER AFTER HE INSERTED THE CORONARY SINUS CATHETER, PR9. HE TRIED REINSERTING THE DEVICE BUT IT STILL LEAKED AND HAD TO MANAGE THE LEAKING DURING THE CASE. THEY DID NOT SAVE THE NON FUNCTIONING ONE. NO PATIENT ISSUES OCCURRED. THEY DID OPEN A SECOND INTRODUCER FOR THE CASE. NO PATIENT INJURY WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18610 CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9

    Patients

    Seq Age Sex Outcome Treatment
    1