BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX BILIARY

    MDR report key: 3901052 · Received June 30, 2014

    Report

    Report Number
    3005099803-2014-02420
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    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

    A VISUAL ANALYSIS FOUND THE PUSH CATHETER WAS DETACHED AT THE GUIDE WIRE RAMP BY THE DISTAL TIP. THE DETACHED REMNANT OF THE PUSH CATHETER REMAINED LOADED ONTO THE PULLWIRE. THE DETACHMENT POINT REVEALED THAT THE PLASTIC EXTRUSION APPEARED STRETCHED TO THE POINT OF FATIGUE FAILURE. THE MATERIAL WAS DEFORMED, DISCOLORED AND THE OUTER DIAMETER WAS REDUCED. A FUNCTIONAL ANALYSIS WAS NOT PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE PULLWIRE WAS REMOVED FROM THE REMAINDER OF THE PUSH CATHETER, ONCE REMOVED IT WAS NOTED TO BE BENT BY THE PROXIMAL END OF THE HUB. THE GUIDE CATHETER WAS KINKED BY THE DISTAL END. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THE REPORTED FAILURE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED TO BE OVER 18 YEARS OF AGE. REPORTED EVENT OF PUSH CATHETER BREAK. 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 RX BILIARY STENT WAS USED DURING A PLACEMENT OF BILIARY STENT PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE STENT, RESISTANCE WAS ENCOUNTERED BUT WAS ABLE TO DEPLOY THE DEVICE. HOWEVER, WHEN REMOVING THE PUSH CATHETER AND GUIDEWIRE, THE PHYSICIAN NOTICED THAT THE PUSH CATHETER WAS DETACHED AT THE GUIDE WIRE PORT. THE DETACHED PUSH CATHETER REMAINED INSIDE THE SCOPE AND WAS SUCCESSFULLY REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH THIS 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 RX BILIARY STENT WAS USED DURING A PLACEMENT OF BILIARY STENT PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE STENT, RESISTANCE WAS ENCOUNTERED BUT WAS ABLE TO DEPLOY THE DEVICE. HOWEVER, WHEN REMOVING THE PUSH CATHETER AND GUIDEWIRE, THE PHYSICIAN NOTICED THAT THE PUSH CATHETER WAS DETACHED AT THE GUIDE WIRE PORT. THE DETACHED PUSH CATHETER REMAINED INSIDE THE SCOPE AND WAS SUCCESSFULLY REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH THIS 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
    380106 RX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00545550 16830810

    Patients

    Seq Age Sex Outcome Treatment
    1