BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMTOME RX SPHINCTEROTOME

    MDR report key: 1970186 · Received January 25, 2011

    Report

    Report Number
    3005099803-2011-00106
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH/DISTAL TIP WITH EXPOSED CUT WIRE WAS TWISTED AND BENT. INVESTIGATING THE CANNULATING ORIENTATION OF THE DEVICE BY INSERTING THE DEVICE INTO AN ENDOSCOPE, IT WAS FOUND THAT THE INITIAL TIP ORIENTATION DID NOT MEET THE ORIENTATION SPECIFICATION OF BETWEEN 9:00 AM AND 2:00 PM. THE ORIENTATION OF THE DISTAL TIP COULD BE ADJUSTED LEFT OR RIGHT BY ROTATING THE HANDLE BUT COULD NOT BE SET WITHIN SPECIFICATION DUE TO THE TWISTED WORKING LENGTH AND BENT/MISALIGNED WIRE. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE WOULD BOW PAST 90 DEGREES WHICH MEETS THE BOWING SPECIFICATION OF 90 DEGREE MINIMUM BUT THE BOWING WAS NOT IN PLANE (CANNULATING WIRE MOVEMENT) DUE TO THE BENT/MISALIGNED WIRE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CUTTING WIRE WAS TWISTED AT THE DISTAL END AND THAT THE CUT WIRE DID NOT BOW IN LINE WITH THE CATHETER (IN PLANE). DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED SO THE TWISTED WORKING LENGTH AND BENT/MISALIGNED WIRE ARE LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO BOW THE SPHINCTEROTOME, THE SPHINCTEROTOME DID NOT BOW IN LINE WITH THE CATHETER; INSTEAD, IT APPEARED TO BOW IN A TWISTED/HELICAL SHAPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME 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 DREAMTOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO BOW THE SPHINCTEROTOME, THE SPHINCTEROTOME DID NOT BOW IN LINE WITH THE CATHETER; INSTEAD, IT APPEARED TO BOW IN A TWISTED/HELICAL SHAPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME 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 DREAMTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00584000 13718834

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR