BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 2143132 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02245
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE IS UNKNOWN, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. 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 REVEALED THAT THE WORKING LENGTH WAS TWISTED, THE EXPOSED CUT WIRE WAS DISCOLORED AND APPEARED TO HAVE MELTED/SPLIT THE EXTRUSION AT THE DISTAL PIERCE HOLE. THE MELTED EXTRUSION, CREATED A TEAR MEASURING APPROXIMATELY 7MM PROXIMALLY FROM THE DISTAL PIERCE HOLE. THIS TEAR ALLOWED THE CUTTING WIRE WITH THE ATTACHED ANCHOR TO SEPARATE FROM THE DISTAL PIERCE HOLE. THOUGH, THE CUT WIRE WITH ATTACHED ANCHOR SEPARATED FROM THE DISTAL PIERCE HOLE, IT REMAINED ATTACHED AT THE PROXIMAL PIERCE HOLE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE CUT WIRE WAS BROKE, HOWEVER, THE CONDITION OF THE INDICATES THE DEVICE WAS USED (CURRENT HAD BEEN APPLIED TO THE DEVICE). THE MOST PROBABLE ROOT CAUSE IS LIKELY DUE TO HANDLING DURING PREPARATION, THEREFORE, THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX SPHINCTEROTOME WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE DEVICE WAS REMOVED FROM THE PACKAGE AND IT WAS DISCOVERED THAT THE CUTTING WIRE WAS BROKEN. NO VISIBLE DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS 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 TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE DEVICE WAS REMOVED FROM THE PACKAGE AND IT WAS DISCOVERED THAT THE CUTTING WIRE WAS BROKEN. NO VISIBLE DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS 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 M00583040

    Patients

    Seq Age Sex Outcome Treatment
    1