BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2944416 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00389
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE COIL WAS SEVERELY ELONGATED AND UNRAVELED, ADDITIONALLY THE COATING IS SCRAPPED IN SOME SECTIONS ALONG THE ENTIRE BODY AND THE UNIT IS BENT. THE VISUAL INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS: THE DISTAL END SERIOUSLY DAMAGED (ELONGATED, UNRAVELED AND CORE WIRE FRACTURED). ALL THE MEASURES WERE FOUND TO BE WITHIN SPECIFICATIONS MTAC ANALYSIS REVEALED THAT THE SEPARATION OCCURRED DUE TO A TENSION OVERLOAD. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE (PCI), DIFFICULTY REMOVING OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A NON-BSC CATHETER WAS PLACED. THE 035/260 AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED INTO THE PATIENT. DURING WITHDRAWAL, THE NON-BSC CATHETER AND THE GUIDE WIRE BECAME STUCK TOGETHER. THE CATHETER AND THE GUIDE WIRE WERE REMOVED FROM THE PATIENT TOGETHER AS ONE UNIT. THE PHYSICIAN PULLED HARD AND REMOVED THE WIRE, AND AS HE DID THE WIRE BEGAN TO FRAY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE (PCI), DIFFICULTY REMOVING OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A NON-BSC CATHETER WAS PLACED. THE 035/260 AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED INTO THE PATIENT. DURING WITHDRAWAL, THE NON-BSC CATHETER AND THE GUIDE WIRE BECAME STUCK TOGETHER. THE CATHETER AND THE GUIDE WIRE WERE REMOVED FROM THE PATIENT TOGETHER AS ONE UNIT. THE PHYSICIAN PULLED HARD AND REMOVED THE WIRE, AND AS HE DID THE WIRE BEGAN TO FRAY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49252 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001465260 15548949

    Patients

    Seq Age Sex Outcome Treatment
    1