BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 1082643 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02052
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    April 28, 2008
    Report Date
    July 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED DEVICE ANALYSIS VERIFIED THE DIFFICULTY STATED IN THE COMPLAINT. THE GUIDE WIRE WAS RECEIVED STUCK INSIDE OF A CATHETER IDENTIFIED AS A SENTINOL SDS. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE GUIDE WIRE FROM THE CATHETER. APPROXIMATELY 3.5 CM OF THE GUIDE WIRE WAS EXPOSED DISTALLY FROM THE TIP OF THE CATHETER AND 95 CM OF THE GUIDE WIRE WAS EXPOSED PROXIMALLY FROM THE PROXIMAL HUB OF THE CATHETER. THE EXPOSED DISTAL SEGMENT OF THE GUIDE WIRE EXHIBITED MULTIPLE BENDS. THE EXPOSED PROXIMAL SEGMENT OF THE GUIDE WIRE REVEALED MISSING COATING FROM 54.5 CM TO 70.5 CM AND 68 CM TO 70.5 CM DISTAL TO THE PROXIMAL TIP OF THE GUIDE WIRE. THE OUTSIDE DIAMETER (OD) OF THE EXPOSED SEGMENTS OF THE GUIDE WIRE WAS FOUND TO BE WITHIN SPECIFICATIONS. THE INVESTIGATION CONDUCTED FAILED TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE BASED ON THE EVIDENCE PRESENTED BY THE INCIDENT DEVICE. THEREFORE, THE ROOT CAUSE IS CONSIDERED UNDETERMINABLE.

    Description of Event or Problem · 1

    EVENT BECAME REPORTABLE BASED UPON ANALYSIS COMPLETED ON 07/21/2008. IT WAS REPORTED THAT DURING A PERIPHERAL STENTING PROCEDURE, TRACKING DIFFICULTIES WERE ENCOUNTERED. THE LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING ADVANCEMENT OF THE SENTINOL BILIARY STENT DELIVERY SYSTEM (SDS) OVER THE AMPLATZ GUIDE WIRE, THE SDS BECAME STUCK. THEREFORE, THE SDS AND THE GUIDE WIRE WERE REMOVED AS A UNIT, AND ANOTHER SENTINOL SDS AND A NON-BSC GUIDE WIRE USED TO COMPETE THE PROCEDURE SUCCESSFULLY. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS LISTED AS "GOOD." ANALYSIS REVEALED MISSING PTFE COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1