BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX CHOLANGIOGRAM KIT

    MDR report key: 1832463 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03854
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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): 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 CHOLANGIOGRAM KIT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE ERCP PROCEDURE, THE JAGTOME RX SPHINCTEROTOME COMPONENT OF THE KIT WOULD NOT PASS THROUGH THE SCOPE. THEY REMOVED THE FIRST SCOPE AND USED A SECOND RX CHOLANGIOGRAM KIT AND ANOTHER SCOPE TO COMPLETE THE CASE. IT WAS DISCOVERED AFTER THE FIRST SCOPE CAME BACK FROM BEING REPAIRED THAT THE SPONGE FROM THE BIOPSY CAP COMPONENT OF THE KIT HAD DISLODGED AND WAS FOUND INSIDE THE SCOPE. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX CHOLANGIOGRAM KIT UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00575281

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR