BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUAL LUMEN EMBOLECTOMY CATHETER, 4F, 40CM

    MDR report key: 909795 · Received September 10, 2007

    Report

    Report Number
    2027111-2007-00065
    Event Type
    Other
    Date Received
    September 10, 2007
    Date of Event
    July 20, 2007
    Report Date
    August 23, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    DXE
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    R/T

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: ONE CATHETER WAS RETURNED FROM AMERICAN ACCESS CARE. INSPECTION OF THE RETURNED CATHETER FOUND THAT THE BALLOON COULD NOT BE INFLATED USING AIR DUE TO A WHITE SUBSTANCE THAT WAS STUCK INSIDE THE LUMEN (HUB) AND THE BODY. IT IS UNCLEAR WHY A WHITE SUBSTANCE WAS BLOCK INSIDE THE LUMEN/BODY. NONE OF THE ABOVE LOT REMAINS IN FINISHED GOOD. CONCLUSION/CORRECTIVE ACTION. THE CAUSE OF THE CATHETER FAILURE COULD NOT BE DETERMINED. ALL CATHETERS UNDERGO A 100% VISUAL INSPECTION AND LEAK TEST DURING PRODUCTION. IN ADDITION TO THIS TESTING, AN AQL SAMPLE IS TAKEN FROM EACH SHOP ORDER BY QC, THEN VISUALLY INSPECTED, LEAK AND PULL TESTED PRIOR TO STERILIZATION. ALL CATHETERS SAMPLED MUST REACH THE MINIMUM SPECIFICATION PULL FORCE PRIOR TO FAILURE. PRODUCT WAS REVIEWED AND HAVE NO DEVIATION. ALL SAMPLES PASSED SPECIFICATION LISTED IN THE MI, QI AND DRAWING. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    "DURING A THROMBECTOMY PROCEDURE 2 DIFFERENT PYTHONS WERE USED FROM THE SAME LOT NUMBER. BOTH WOULD NOT INFLATE AND DEFLATE PROPERLY. ONE WAS POPPED WHILE BEING REMOVED FROM SHEATH." PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL LUMEN EMBOLECTOMY CATHETER, 4F, 40CM EMBOLECTOMY CATHETER DXE APPLIED MEDICAL RESOURCES CORP. A4E03 1035809

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other