BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROKNIFE XL TRIPLE LUMEN NEEDLE KNIFE

    MDR report key: 1171465 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04658
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K973826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (UNABLE TO SHEATH NEEDLE). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISCARDED. A DEVICE EVALUATION CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS RECORDED FOR THIS LOT. THE 2008 15-MONTH NEEDLE KNIFE SPHINCTEROTOMES PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON THE EVENT DTAE, THAT A MICROKNIFE XL TRIPLE LUMEN NEEDLE KNIFE DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON THE SAME DAY. ACCORDING TO THE COMPLAINANT, "UPON TRYING TO RESHEATH THE MICROKNIFE AFTER THE PAPILLECTOMY, THE SHEATH DID NOT GO OVER THE NEEDLE. THE PHYSICIAN PLACED THE NEEDLE PARTIALLY IN THE [ENDO]SCOPE, THEN PULLED OUT THE SCOPE AND MICROKNIFE TOGETHER TO AVOID PT INJURY AND [ENDO ]SCOPE DAMAGE." THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE (PRODUCT AND MANUFACTURER UNK). ALTHOUGH THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS "UNK" THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROKNIFE XL TRIPLE LUMEN NEEDLE KNIFE KNS BOSTON SCIENTIFIC CORPORATION M00532810 11327655

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK