BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA¿ BILIARY

    MDR report key: 2955650 · Received February 11, 2013

    Report

    Report Number
    3005099803-2013-00625
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE STENT WAS STILL LOADED ON THE DISTAL END OF THE GUIDE CATHETER. THE GUIDE CATHETER WAS BROKEN; THE PROXIMAL END WAS STRETCHED, BUCKLED AND STUCK ON A NON-BSC GUIDEWIRE. THE SUTURE WAS INTACT, THERE WAS A SUTURE MARK NEAR THE DISTAL END OF THE GUIDE CATHETER AND THE SUTURE HOLE WAS PARTIALLY TORN. THE PROXIMAL HUB OF THE PUSH CATHETER WAS MISSING AND THE PUSH CATHETER WAS BROKEN. THE NOTED DAMAGES INDICATE DIFFICULTY WAS EXPERIENCED DURING DEPLOYMENT AND ARE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. 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 DRAINAGE PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT THERE WAS RESISTANCE, THE GUIDE CATHETER BROKE AND THE STENT FAILED TO DEPLOY. THE BROKEN GUIDE CATHETER BECAME STUCK ON A NON-BSC GUIDEWIRE AND THE PUSH CATHETER WAS TORN. THE FLEXIMA DEVICE AND THE GUIDEWIRE WERE REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WAS NO DAMAGE NOTED TO THE DEVICE PRIOR TO USE. 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. ADDITIONAL INFORMATION CONFIRMED THAT AFTER THE GUIDE CATHETER BECAME STUCK, THE PUSH CATHETER WAS INTENTIONALLY TORN BY THE USER AND THEY ATTEMPTED TO RELEASE THE STENT AGAIN WITHOUT SUCCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING A DRAINAGE PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT THERE WAS RESISTANCE, THE GUIDE CATHETER BROKE AND THE STENT FAILED TO DEPLOY. THE BROKEN GUIDE CATHETER BECAME STUCK ON A NON-BSC GUIDEWIRE AND THE PUSH CATHETER WAS TORN. THE FLEXIMA DEVICE AND THE GUIDEWIRE WERE REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WAS NO DAMAGE NOTED TO THE DEVICE PRIOR TO USE. 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
    58444 FLEXIMA¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00539270 15531155

    Patients

    Seq Age Sex Outcome Treatment
    1