BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX BILIARY

    MDR report key: 2183319 · Received July 28, 2011

    Report

    Report Number
    3005099803-2011-02537
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT COMPRISED OF THE DELIVERY SYSTEM ONLY; THE STENT WAS NOT RETURNED FOR EVALUATION. VISUAL EVALUATION REVEALED THE GUIDE CATHETER ASSEMBLY TO BE DETACHED FROM THE PULL WIRE. THE WORKING LENGTH OF THE GUIDE CATHETER WAS FOUND INTACT (UNBROKEN), HOWEVER, THE PROXIMAL END OF THE GUIDE CATHETER WAS NOTED TO BE KINKED AND SLIGHTLY STRETCHED. NO SPLITS OR TEARS WERE NOTED TO THE PROXIMAL END OF THE GUIDE CATHETER. THE OVERALL LENGTH OF GUIDE CATHETER MEASURED APPROXIMATELY 32.5CM WHICH DOES NOT MEET THE GUIDE CATHETER CUT LENGTH SPECIFICATION OF 32.0CM +/- 1MM; THE INCREASED LENGTH OF THE GUIDE CATHETER IS DUE TO IT BEING STRETCHED. THE PUSH CATHETER ASSEMBLY WAS FOUND TO BE BENT AT MULTIPLE LOCATIONS. THE PROXIMAL END OF THE PUSH CATHETER WAS FOUND TO BE SEVERELY BUCKLED AND TORN, EXPOSING THE PULL WIRE. THE RAMP ON PUSH CATHETER WAS NOTED TO BE TORN. THE PULL WIRE WAS FOUND TO BE BENT AT THE PROXIMAL END. NO DAMAGE WAS NOTED TO THE WELDED CANNULA/PULL WIRE ASSEMBLY. THE NOTED DAMAGES LIKELY OCCURRED AS A RESULT OF EXCESS FORCE ON THE DEVICE DURING THE PROCEDURE DUE TO PROCEDURAL OR ANATOMICAL FACTORS (SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE). THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED; HOWEVER THE EVALUATION HAS NOT YET BEEN COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT SYSTEM WAS USED DURING A PROCEDURE IN A (B)(6) FEMALE PATIENT (PATIENT WEIGHT IS UNKNOWN). DURING THE PROCEDURE, THE GUIDE CATHETER SEPARATED FROM THE PULL WIRE, AND THE STENT WAS UNABLE TO BE DEPLOYED. THERE WERE NO REPORTED PATIENT COMPLICATIONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT SYSTEM WAS USED DURING A PROCEDURE IN A (B)(6) OLD FEMALE PATIENT (PATIENT WEIGHT IS UNKNOWN). DURING THE PROCEDURE, THE GUIDE CATHETER SEPARATED FROM THE PULL WIRE, AND THE STENT WAS UNABLE TO BE DEPLOYED. THERE WERE NO REPORTED PATIENT COMPLICATIONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00545690 13710840

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR