BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA? BILIARY

    MDR report key: 3894069 · Received June 25, 2014

    Report

    Report Number
    3005099803-2014-02332
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND OUT THAT THE GUIDE CATHETER WAS RETURNED DETACHED INTO THREE SECTIONS. ALL THREE SECTIONS OF THE GUIDE CATHETER WERE KINKED/BENT AND STRETCHED, AND ONE SECTION WAS STUCK ON THE GUIDEWIRE. THE STENT WAS RETURNED WITHOUT DEFECTS. THE PUSH CATHETER WAS NOT RETURNED FOR EVALUATION, AND THE REASON FOR THE GUIDE CATHETER DETACHING COULD NOT BE DETERMINED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. A REVIEW OF THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) SHOWED THE DEVICE WAS USED ACCORDING TO ITS LABEL.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4) GUIDE CATHETER BROKE. 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 FLEXIMA BILIARY STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014 IN THE BILE DUCT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN THE PHYSICIAN WAS RELEASING THE STENT. THE PHYSICIAN CONTINUED THE PROCEDURE AND RELEASED THE STENT. HOWEVER, THE GUIDE CATHETER BROKE AND PART OF IT REMAINED IN THE STENT INSIDE THE PATIENT. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH THE SAME DEVICE. 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 FLEXIMA BILIARY STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014 IN THE BILE DUCT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN THE PHYSICIAN WAS RELEASING THE STENT. THE PHYSICIAN CONTINUED THE PROCEDURE AND RELEASED THE STENT. HOWEVER, THE GUIDE CATHETER BROKE AND PART OF IT REMAINED IN THE STENT INSIDE THE PATIENT. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH THE SAME DEVICE. 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
    371936 FLEXIMA? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00539270

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention