BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 3221214 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04622
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. THE UNIT RETURNED PRESENTED THE COIL WIRE STRETCHED, AS PART OF OVERALL VISUAL REVISION. THE VISUAL INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS THE DISTAL END SEVERELY BENT AT 240.0CM APPROX. FROM THE PROXIMAL END TO DISTAL END. MOREOVER, THE COIL ON THE DISTAL END IS STRETCHED. ALL THE OUTER DIAMETER TAKEN ARE WITHIN SPECIFICATIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, PEELING OF THE GUIDE WIRE COATING OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE PHYSICIAN WAS CURVING A 035/260 AMPLATZ SUPER STIFF GUIDE WIRE WITH A 6F UNSPECIFIED PLASTIC DILATOR WHEN THE COATING OF THE DISTAL PORTION OF THE DEVICE STRIPPED OFF IN PLACES. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, PEELING OF THE GUIDE WIRE COATING OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE PHYSICIAN WAS CURVING A 035/260 AMPLATZ SUPER STIFF GUIDE WIRE WITH A 6F UNSPECIFIED PLASTIC DILATOR WHEN THE COATING OF THE DISTAL PORTION OF THE DEVICE STRIPPED OFF IN PLACES. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320823 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001465260 15140499

    Patients

    Seq Age Sex Outcome Treatment
    1