BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1830375 · Received September 10, 2010

    Report

    Report Number
    3005099803-2010-03829
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4): THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED AND THE DISTAL TIP WAS CRACKED/SPLIT. THE EXPOSED CUT WIRE WAS FOUND TO BE INTACT. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE WAS ABLE TO BOW WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE DEVICE'S TIP WAS KINKED AND BENT, HOWEVER, THE TIP WAS DAMAGED (CRACKED/SPLIT). DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE CRACKED/SPLIT DISTAL TIP IS LIKELY DUE TO INTERACTION WITH THE SCOPE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS DEVICE INTERACTION WITH ANOTHER DEVICE. THE INVESTIGATION RESULTS CONFIRMED THE TIP WAS NOT KINKED AND BENT, THEREFORE, THIS IS NO LONGER CONSIDERED A REPORTABLE EVENT.

    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. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS ADVANCED DOWN THE ENDOSCOPE, UPON EXITING IT WAS NOTED THAT THE TIP WAS KINKED AND BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX 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.

    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. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS ADVANCED DOWN THE ENDOSCOPE, UPON EXITING IT WAS NOTED THAT THE TIP WAS KINKED AND BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX 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 HYDRATOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00583050

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR