BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY GUIDEWIRE

    MDR report key: 2141712 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02462
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    May 28, 2011
    Report Date
    June 2, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: ANALYSIS OF THE RETURNED DEVICE REVEALED THE CORE WIRE WAS FRACTURED. THE DISTAL TIP INCLUDING THE 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. THE FRACTURE FACE WAS BENT. SEM LAB ANALYSIS CONCLUDED THE CORE WIRE FRACTURED FROM A DUCTILE TORSION/TENSION OVERLOAD OF THE NITINOL CORE WIRE. . THE MANUFACTURING BATCH RECORD REVIEW COULD NOT BE COMPLETED AS THE BATCH NUMBER WAS UNKNOWN. 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

    IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE, THE GUIDE WIRE BROKE. THE TARGET LESION WAS LOCATED BELOW THE KNEE IN THE TIBIAL ARTERY. IT WAS NOTED THIS PATIENT HAD A "SHARP ANGULAR TAKE-OFF" AND RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE JOURNEY GUIDE WIRE. WHILE ATTEMPTING TO CROSS THE LESION, THE WIRE SNAPPED ON THE PROXIMAL END. THE WIRE WAS SNARED FROM THE PATIENT SUCCESSFULLY. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE, THE GUIDE WIRE BROKE. THE TARGET LESION WAS LOCATED BELOW THE KNEE IN THE TIBIAL ARTERY. IT WAS NOTED THIS PATIENT HAD A "SHARP ANGULAR TAKE-OFF" AND RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE JOURNEY GUIDE WIRE. WHILE ATTEMPTING TO CROSS THE LESION, THE WIRE SNAPPED ON THE PROXIMAL END. THE WIRE WAS SNARED FROM THE PATIENT SUCCESSFULLY. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention