BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1904002 · Received November 20, 2010

    Report

    Report Number
    3005099803-2010-04861
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ADDITIONAL INTERVENTION REQUIRED. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS RETAINED 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 A HYDRATOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE HYDRATOME WAS POSITIONED AT THE AMPULLA TO PERFORM A SPHINCTEROTOMY. HOWEVER, DURING THE SPHINCTEROTOMY, A SPARK WAS SEEN AND AFTERWARDS THE SPHINCTEROTOME FAILED TO BOW. THE SPHINCTEROTOME WAS EXTRACTED OUT FROM THE AMPULLA. AT THIS TIME, IT WAS DISCOVERED THAT THE CUTTING WIRE HAD SNAPPED APPROXIMATELY MIDWAY DOWN THE CUTTING WIRE REGION. THE DISTAL END OF THE WIRE REMAINED ATTACHED TO THE CATHETER TIP. HOWEVER, AT THE PROXIMAL END OF THE CUTTING WIRE REGION, ONLY A SMALL LENGTH OF THE WIRE WAS SEEN TO BE ATTACHED. THE REMAINING SECTION OF THE WIRE APPEARED TO BE MISSING. THE HYDRATOME WAS REMOVED FROM THE PATIENT. THE PHYSICIAN USED A RETRIEVAL BALLOON TO SWEEP THE DUCT IN AN ATTEMPT TO RETRIEVE THE FRAGMENT. HOWEVER, THE PHYSICIAN WAS UNABLE TO LOCATE A FRAGMENT OF WIRE. ANOTHER DEVICE (AUTOTOME SPHINCTEROTOME) WAS THEN USED TO ENLARGE AND COMPLETE THE SPHINCTEROTOMY. THE RETRIEVAL BALLOON WAS REINTRODUCED INTO THE PATIENT AND SEVERAL STONES WERE REMOVED. FOLLOW UP CONFIRMED THAT THE WIRE HAD ONLY BROKEN IN ONE PLACE AND WAS PULLED BACK UP INSIDE THE CATHETER MAKING IT APPEAR THAT A PIECE OF THE WIRE WAS MISSING. THERE WERE NO KNOWN 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 HYDRATOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00583010 13749134

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention