BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT²¿

    MDR report key: 2961457 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00613
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE VISUAL INSPECTION WAS PERFORMED AND FOUND THAT THE DEVICE IS PEELED ALONG THE BODY AT: 18.2CM TO 21.2CM, 52.7CM TO 55.2CM, 86.2CM TO 88.6CM, 119.1CM TO 121.5CM, 143.6CM TO 145.3CM, ALL OF THEM FROM THE PROXIMAL END. THE DOWEL TEST WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE PTFE WAS PROPERLY ATTACHED TO THE GUIDEWIRE. ALL THE MEASURES TAKEN ARE ACCORDING SPECIFICATIONS. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE A PERCUTANEOUS CORONARY INTERVENTION (PCI) GUIDEWIRE BREAKAGE OCCURRED. AFTER OPENING THE PT2 GUIDEWIRE PACKAGE, SOME DIFFICULTY TO INSERT THE WIRE WAS REPORTED. WHEN IT WAS EXAMINED, IT WAS FOUND THAT THE MID-PART LOOKED LIKE AS IT WAS SEPARATED FROM THE WIRE, OR IT SEEMED AS A CUTTING OFF PORTION FROM THE WIRE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE A PERCUTANEOUS CORONARY INTERVENTION (PCI) GUIDEWIRE BREAKAGE OCCURRED. AFTER OPENING THE PT² GUIDEWIRE PACKAGE, SOME DIFFICULTY TO INSERT THE WIRE WAS REPORTED. WHEN IT WAS EXAMINED, IT WAS FOUND THAT THE MID-PART LOOKED LIKE AS IT WAS SEPARATED FROM THE WIRE, OR IT SEEMED AS A CUTTING OFF PORTION FROM THE WIRE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64778 PT²¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H7493893103J0

    Patients

    Seq Age Sex Outcome Treatment
    1