BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC BILIARY CATHETER

    MDR report key: 2010988 · Received March 8, 2011

    Report

    Report Number
    3005099803-2011-00729
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 21, 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 OF THE RETURNED DEVICE FOUND THAT THE EXPOSED CUTTING WIRE WAS INTACT BUT DISCOLORED FROM USE. THE CUTTING WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION AND A FUNCTIONAL EVALUATION FOUND THE DEVICE TO BOW WITHIN SPECIFICATION. A SECOND FUNCTIONAL EVALUATION OF THE CONTINUITY BETWEEN THE 2-IN-1 CONNECTOR AND THE EXPOSED CUTTING WIRE FOUND THE DEVICE TO BE ABLE TO CONDUCT CURRENT INDICATING PROPER CONNECTIVITY OF THE DEVICE. THE 2-IN-1 CONNECTOR WAS INTACT AND AN ACTIVE CORD CONNECTOR COULD BE CONNECTED TO THE 2-IN-1 CONNECTOR WITHOUT ANY ISSUES. THE RESISTANCE ACROSS THE 2-IN-1 CONNECTED AND THE CUTTING WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE CONNECTING PART OF THE DEVICE WAS EXTENDED AND IT WAS UNABLE TO APPLY ELECTRIC CURRENT TO THE DEVICE. THE COMPLAINT WAS NOT CONFIRMED. 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 STONETOME SPHINCTEROTOME WAS TO BE USED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ACTIVE CORD CONNECTOR COULD NOT BE FITTED ONTO THE ACTIVE CORD. NO VISIBLE DAMAGE WAS NOTED TO THE CONNECTOR. THE CONNECTOR WAS EXTENDED/FLARED IN ORDER TO CONNECT THE DEVICE TO THE ACTIVE CORD. HOWEVER, ELECTRICAL CURRENT WAS UNABLE TO BE APPLIED TO THE SPHINCTEROTOME. THE PROCEDURE WAS COMPLETED USING ANOTHER STONETOME SPHINCTEROTOME IN CONJUNCTION WITH THE SAME 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 TO BE USED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ACTIVE CORD CONNECTOR COULD NOT BE FITTED ONTO THE ACTIVE CORD. NO VISIBLE DAMAGE WAS NOTED TO THE CONNECTOR. THE CONNECTOR WAS EXTENDED/FLARED IN ORDER TO CONNECT THE DEVICE TO THE ACTIVE CORD. HOWEVER, ELECTRICAL CURRENT WAS UNABLE TO BE APPLIED TO THE SPHINCTEROTOME. THE PROCEDURE WAS COMPLETED USING ANOTHER STONETOME SPHINCTEROTOME IN CONJUNCTION WITH THE SAME 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 M00535110 13812638

    Patients

    Seq Age Sex Outcome Treatment
    1