BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY GUIDEWIRE

    MDR report key: 2181732 · Received July 27, 2011

    Report

    Report Number
    2134265-2011-03013
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE DE NOVO SUBTOTAL OCCLUSION WAS LOCATED IN THE MILDLY TORTUOUS RIGHT POPLITEAL ARTERY. THE PHYSICIAN ADVANCED THE 185CM JOURNEY GUIDE WIRE TO THE LESION WITHOUT ANY RESISTANCE AND WHILE ATTEMPTING TO CROSS THE LESION THE TIP BROKE OFF AND REMAINED IN THE PATIENT. NO ACTIONS WERE TAKEN TO RETRIEVE THE FRAGMENT "BECAUSE THE TIP IS SAFE INTRAMURAL IN THE VESSEL WALL." THE PROCEDURE WAS COMPLETED WITH A V18 GUIDE WIRE AND A NON-BSC BALLOON. PER THE PHYSICIAN, THE GUIDE WIRE FRAGMENT DID NOT CONSTRICT THE RECANALIZATION. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001391260 0013857522

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other