BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC BILIARY CATHETER

    MDR report key: 2021534 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00924
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQR
    PMA / PMN Number
    K946358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 FOUND THAT THE WORKING LENGTH WAS TWISTED. THE LENGTH AND THE OUTER DIAMETER OF THE EXPOSED CUTTING WIRE WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE MET THE MINIMUM BOWING SPECIFICATION. A SECOND FUNCTION EVALUATION FOUND THAT THE CONTINUITY BETWEEN THE 2-IN-1 CONNECTOR AND THE EXPOSED CUTTING WIRE WAS ABLE TO CONDUCT CURRENT. THE RESISTANCE ACROSS THE 2-IN-1 CONNECTOR AND THE CUTTING WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT ENERGY WAS UNABLE TO BE DELIVERED TO THE CUTTING WIRE. THE COMPLAINT WAS NOT CONFIRMED. A SEARCH OF THE COMPLAINT DATABASE FOUND 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 STONETOME SPHINCTEROTOME WAS USED DURING A STONE REMOVAL PROCEDURE WITHIN THE COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE FAILED TO DELIVER ELECTRICAL CURRENT AND ACTIVATE THE CUTTING WIRE. AS A RESULT, THE DEVICE DID NOT CUT AT THE TARGET SITE. NO VISIBLE ISSUES WERE NOTED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME SPHINCTEROTOME IN CONJUNCTION WITH THE SAME GENERATOR AND ACTIVE CORD. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME SPHINCTEROTOME WAS USED DURING A STONE REMOVAL PROCEDURE WITHIN THE COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE FAILED TO DELIVER ELECTRICAL CURRENT AND ACTIVATE THE CUTTING WIRE. AS A RESULT, THE DEVICE DID NOT CUT AT THE TARGET SITE. NO VISIBLE ISSUES WERE NOTED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME SPHINCTEROTOME IN CONJUNCTION WITH THE SAME GENERATOR AND ACTIVE CORD. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC BILIARY CATHETER DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC - SPENCER M00535130 13732298

    Patients

    Seq Age Sex Outcome Treatment
    1