BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT²¿

    MDR report key: 2991465 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01262
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    November 21, 2012
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE VISUAL INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS: THE DISTAL TIP DAMAGED, THE DEVICE HAS TWO KINKS AT 0.5 CM AND 17 8 CM FROM THE PROXIMAL END, AND THREE BENTS AT 176 CM, 180 CM AND 183.3 CM FROM THE PROXIMAL END. ALSO, THE DISTAL TIP OF THE WIRE PRESENTS EVIDENCE OF SEPARATION OF THE RIBBON. ALL THE MEASUREMENTS TAKEN WERE FOUND BE WITHIN SPECIFICATIONS. THE RETURNED DEVICE WAS SENT FOR EXTERNAL ANALYSIS TO DETERMINE THE FRACTURE FAILURE MODE WHICH REVEALED THE FRACTURE OCCURRED DUE TO A SHEAR/TEAR 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2013 IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE (PCI), THE GUIDE WIRE TIP WAS DAMAGED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). WHILE DELIVERING THE 185 CM PT2 GUIDE WIRE INTO THE PATIENT, THE PHYSICIAN NOTED THAT THE TIP OF THE DEVICE WAS LIFTED UP. THE DEVICE WAS REMOVED AND THE PHYSICIAN ELECTED TO STOP THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER DEVICE ANALYSIS REVEALED THAT THE RIBBON OF THE DEVICE WAS SEPARATED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96036 PT²¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74938931030 13925066

    Patients

    Seq Age Sex Outcome Treatment
    1