BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPHINCTEROTOME

    MDR report key: 1911108 · Received November 30, 2010

    Report

    Report Number
    3005099803-2010-04960
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K973826
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) - (INTERVENTION REQUIRED TO REMOVE CUT WIRE FRAGMENT). (B)(4) - THE REPORTED EVENT OF WIRE BROKEN. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE SPHINCTEROTOMY, THE WIRE AT THE END OF THE RX NEEDLE KNIFE BROKE INSIDE THE PATIENT LEAVING A SMALL FRAGMENT OF WIRE IMPACTED IN THE PAPILLA. THE PHYSICIAN WITHDREW THE DEVICE AND USED GASTRO PEDIATRIC FORCEPS TO REMOVE THE WIRE FRAGMENT AND FEELS CONFIDENT THE FRAGMENT WAS REMOVED INTO THE SCOPE, BUT DID NOT FIND IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX NEEDLE KNIFE SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00545840

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention