BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY GUIDEWIRE

    MDR report key: 2050668 · Received April 12, 2011

    Report

    Report Number
    2134265-2011-01252
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE DEVICE REVEALED THE DISTAL TIP; INCLUDING COIL WIRE/CORE WIRE/RIBBON (CCR JOINT) WAS NOT RETURNED FOR ANALYSIS. THE HIGH TORQUE SLEEVE (HTS) MEASURED APPROXIMATELY 6.25IN. A SMALL PORTION OF THE HTS WAS CUT BACK TO REVEAL THE CORE WIRE SHOWING THAT THE CORE WIRE WAS FRACTURED. SEM ANALYSIS OF THE FRACTURE SITE SHOWS THAT APPROXIMATELY HALF THE SURFACE CONTAINS A DIMPLE STRUCTURE WHICH IS INDICATIVE OF A DUCTILE OVERLOAD. THE OTHER HALF OF THE FRACTURE SURFACE WAS SMEARED AND IS SUSPECTED TO BE DUE TO RUBBING AGAINST THE HIGH TORQUE SLEEVE OR THE MATING PORTION OF THE FRACTURE. THE CORE WIRE IS BENT APPROXIMATELY 90 DEGREES IN THE AREA WHERE IT FRACTURED. THE CORE WIRE FRACTURE WAS DUE TO TWISTING AND PULLING TO FAILURE. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY TREATMENT PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS ANTERIOR TIBIAL ARTERY (ATA). THIS 300CM JOURNEY GUIDE WIRE WAS USED TO GAIN ACCESS TO THE LESION. THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING THE GUIDE WIRE INTO THE ATA, AS A RESULT, APPROXIMATELY 2CM OF THE GUIDE WIRE DISTAL TIP DETACHED. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE GUIDE WIRE TIP. THE GUIDE WIRE TIP REMAINS IN A COLLATERAL VESSEL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001391280 13878683

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other TERUMO RADIFOCUS GLIDEWIRE