BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT²¿

    MDR report key: 3051366 · Received April 10, 2013

    Report

    Report Number
    2134265-2013-02089
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 13, 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

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE PRESENTED PEELING ALONG THE BODY AT 23.3CM TO 26.2CM, AT 86.1CM TO 86.4CM, AND AT 139.9CM TO 141.1CM FROM THE PROXIMAL END. THE DEVICE ALSO PRESENTED TWO KINKS AT 120.7CM AND AT 142.5CM FROM THE PROXIMAL END; AND THE DISTAL TIP WAS BENT AT 183.4CM FROM THE PROXIMAL END. DIMENSIONAL INSPECTION MEASUREMENTS WERE WITHIN 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, FAILURE TO CROSS THE LESION OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS CIRCUMFLEX BRANCH. THIS 185CM MODERATE SUPPORT PT2 GUIDE WIRE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING ALONG THE BODY OF THE GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149412 PT²¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74938931030 0015529339

    Patients

    Seq Age Sex Outcome Treatment
    1