BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY GUIDEWIRE

    MDR report key: 2161671 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02615
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 14, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 6.5IN. A SMALL PORTION OF THE HTS WAS CUT BACK TO REVEAL THE CORE WIRE. THE CORE WIRE WAS BENT AT THE LOCATION OF THE FRACTURE. SEM LAB ANALYSIS CONCLUDED THE CORE WIRE FRACTURED DUE TO DUCTILE TORSION/BENDING 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE, THE GUIDE WIRE TIP DETACHED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED PERONEAL ARTERY. THE JOURNEY GUIDE WIRE WAS ADVANCED INTO THE PATIENT. AFTER 5-10 MINUTES OF ATTEMPTING TO "DRILL THROUGH" THE OCCLUSION, A 5MM PORTION OF THE GUIDE WIRE TIP DETACHED. A SECOND JOURNEY GUIDE WIRE WAS THEN ADVANCED, BUT WAS NOT SUCCESSFUL IN CROSSING EITHER. ADDITIONAL FAILED ATTEMPTS WERE MADE WITH MORE THAN ONE NON BSC CTO GUIDE WIRES. NO ATTEMPT WAS MADE TO REMOVE THE JOURNEY GUIDE WIRE TIP AND THE PHYSICIAN IS NOT CONCERNED WITH EMBOLIZATION AS THE TIP IS LODGED IN THE TOTAL OCCLUSION OF THE PERONEAL. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE, THE GUIDE WIRE TIP DETACHED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED PERONEAL ARTERY. THE JOURNEY GUIDE WIRE WAS ADVANCED INTO THE PATIENT. AFTER 5-10 MINUTES OF ATTEMPTING TO ¿DRILL THROUGH¿ THE OCCLUSION, A 5MM PORTION OF THE GUIDE WIRE TIP DETACHED. A SECOND JOURNEY GUIDE WIRE WAS THEN ADVANCED, BUT WAS NOT SUCCESSFUL IN CROSSING EITHER. ADDITIONAL FAILED ATTEMPTS WERE MADE WITH MORE THAN ONE NON BSC CTO GUIDE WIRES. NO ATTEMPT WAS MADE TO REMOVE THE JOURNEY GUIDE WIRE TIP AND THE PHYSICIAN IS NOT CONCERNED WITH EMBOLIZATION AS THE TIP IS LODGED IN THE TOTAL OCCLUSION OF THE PERONEAL. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S 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 M001391290 13846427

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other