BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1821205 · Received August 31, 2010

    Report

    Report Number
    3005099803-2010-03737
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (TIP DOES NOT BOW IN PLANE).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/DISTAL TIP WAS TWISTED. THE EXPOSED CUT WIRE WAS TWISTED AND BENT. THE INITIAL TIP ORIENTATION DID NOT MEET THE ORIENTATION SPECIFICATION DUE TO TWISTED TIP AND BENT WIRE. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE MET THE BOWING SPECIFICATION BUT THE BOWING WAS NOT IN PLANE DUE TO THE BENT WIRE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT OF, THE TIP WENT ASKEW WHEN BOWING THE DEVICE. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE CONDITION OF THE DEVICE IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS NOT STRAIGHT. WHILE BOWING THE DEVICE, THE TIP WENT ASKEW AND AWAY FROM THE AMPULLA. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS NOT STRAIGHT. WHILE BOWING THE DEVICE, THE TIP WENT ASKEW AND AWAY FROM THE AMPULLA. 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 STABLE.

    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 M00583000 13420626

    Patients

    Seq Age Sex Outcome Treatment
    1