BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF?

    MDR report key: 3983713 · Received August 6, 2014

    Report

    Report Number
    3005099803-2014-02626
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISUAL EXAMINATION OF THE RETURNED GUIDEWIRE REVEALED THAT THE WIRE WAS KINKED AND THE DISTAL END WAS SEVERELY DAMAGED. THE COILWIRE WAS UNRAVELED AND COREWIRE WAS BROKEN. MOREOVER, THE BALLWELD WAS NOT RETURNED. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE 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

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT UPN AND DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4) FOR THE EVENT OF CORE WIRE BROKEN. 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 AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED DURING A STENT REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE PUSHING THE STENT WITH THE PUSHER OUT OF THE GUIDEWIRE, THE STENT WAS BUCKLED AND THE GUIDEWIRE UNRAVELED. THE GUIDEWIRE WAS REMOVED FORCIBLY AND IT BROKE INTO TWO, EXPOSING THE CORE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED DURING A STENT REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE PUSHING THE STENT WITH THE PUSHER OUT OF THE GUIDEWIRE, THE STENT WAS BUCKLED AND THE GUIDEWIRE UNRAVELED. THE GUIDEWIRE WAS REMOVED FORCIBLY AND IT BROKE INTO TWO, EXPOSING THE CORE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461339 AMPLATZ SUPER STIFF? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0066401061

    Patients

    Seq Age Sex Outcome Treatment
    1