BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC BILIARY CATHETER

    MDR report key: 2031590 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-01013
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE ORIENTATION ISSUE AND FOUND THE DISTAL TIP TWISTED. THIS WAS LIKELY CAUSED BY ATTEMPTS TO USE THE DEVICE. HOWEVER, IT WAS CONFIRMED THAT THERE WERE NO BENDS/KINKS. BASED ON THESE RESULTS THIS IS NO LONGER A REPORTABLE EVENT. 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC SPHINCTERECTOMY (EST) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE CUT WIRE WAS POINTED AT THE 3 OR 4 O'CLOCK POSITION AND COULD NOT ORIENT TO THE 11 O'CLOCK POSITION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE KINK WAS REPAIRED. THE PHYSICIAN REINSERTED THE DEVICE BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC SPHINCTERECTOMY (EST) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE CUT WIRE WAS POINTED AT THE 3 OR 4 O'CLOCK POSITION AND COULD NOT ORIENT TO THE 11 O'CLOCK POSITION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE KINK WAS REPAIRED. THE PHYSICIAN REINSERTED THE DEVICE BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC BILIARY CATHETER DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC - SPENCER M00535110 13884027

    Patients

    Seq Age Sex Outcome Treatment
    1