BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 1914476 · Received December 3, 2010

    Report

    Report Number
    3008500478-2010-00025
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 10, 2010
    Report Date
    January 17, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: 05/05/2011. DEVICE MANUFACTURE DATE: 08/05/2010. EVALUATION RESULTS: (B)(4) 2011 - THE DISTAL TIP OF THE DEVICE WAS VISUALLY INSPECTED AND IT IS NOTED THAT THE DISTAL TIP OF THE DEVICE IS CRACKED. VISUALLY IT APPEARS AS IF THE DISTAL PORTION OF THE TIP WAS MANIPULATED WHICH CRACKED THE MATERIAL SURROUNDING THE SOFT TIP. VISUALLY UNDER 10X MAGNIFICATION THERE IS EVIDENCE THAT THE DISTAL TIP WAS BENT ENOUGH TO CRACK THE TIP. THE BALLOON BOND IS STILL INTACT. AIR WAS INTRODUCED INTO THE DEVICE BALLOON AND THE BALLOON INFLATED AND HELD INFLATION FOR HALF HOUR WITH NO VOLUME LOSS. WATER WAS INTRODUCED INTO THE PRESSURE AND INFUSION LUMENS 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. WE CAN NOT DETERMINE HOW OR WHERE THE DISTAL TIP BECAME CRACKED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT 763119 AND THIS DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. CURRENT INVESTIGATION DOES NOT INDICATE A MANUFACTURING DEFECT OR A TREND THEREFORE NO CAPA WILL BE INITIATED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ENDOPLEGE THAT THE TIP OF THE CATHETER WAS CRACKED. IT WAS FOUND DURING PREP AND WAS NOT USED IN 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 763119

    Patients

    Seq Age Sex Outcome Treatment
    1