BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC BILIARY CATHETER

    MDR report key: 2001426 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00533
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQR
    PMA / PMN Number
    K946358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH/DISTAL TIP WAS TWISTED AND THE BALLOON WAS TORN/DAMAGED. A FUNCTIONAL EVALUATION WITH AN AIR FILLED SYRINGE FOUND THAT THE BALLOON WOULD NOT INFLATE DUE TO THE TEAR. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE BALLOON DEFLATED. DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED FOR BALLOON INTEGRITY/INFLATION FUNCTIONALITY AND THE TORN BALLOON IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT NUMBER. 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF STONES WITHIN THE COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON ON THE DEVICE WAS INFLATED AND USED TO SWEEP THE BILE DUCT. DURING THE PROCESS OF STONE RETRIEVAL, THE BALLOON DEFLATED. NO PART OF THE BALLOON DETACHED INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN EXTRACTOR XL RETRIEVAL BALLOON. 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 FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS THAT "THE BALLOON WAS TORN/DAMAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC BILIARY CATHETER DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC - SPENCER M00535130 13673939

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR