BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY GUIDEWIRE

    MDR report key: 2161846 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02799
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 15, 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RECEIVED PRODUCT CONSISTED OF A JOURNEY GUIDEWIRE. THE GUIDEWIRE WAS FRACTURED. THE DISTAL TIP, INCLUDING COIL WIRE/CORE WIRE/RIBBON (CCR JOINT) WAS NOT RETURNED FOR ANALYSIS. THE HIGH TORQUE SLEEVE (HTS) MEASURED 5.75IN. A SMALL PORTION OF THE HTS WAS CUT BACK TO REVEAL THE CORE WIRE. THE CORE WIRE WAS FRACTURED. THE CORE WIRE WAS BENT AT THE LOCATION OF THE FRACTURE. ANALYTICAL TEST RESULTS CONCLUDED THE CORE WIRE FRACTURED DUE TO DUCTILE 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STENTING TREATMENT PROCEDURE, GUIDE WIRE TIP DETACHMENT OCCURRED. ACCESS WAS GAINED VIA THE LEFT FEMORAL ARTERY. THE 80MM LONG AND ECCENTRIC DE NOVO TARGET LESION WAS LOCATED IN THE TOTALLY OCCLUDED, NON-TORTUOUS AND MODERATELY CALCIFIED LEFT COMMON FEMORAL ARTERY WITH A REFERENCE VESSEL DIAMETER OF 8MM. ACCESS WAS GAINED USING A 4F NON-BSC SHEATH WITH NO GUIDE CATHETER. A 185CM JOURNEY GUIDE WIRE WAS ADVANCED THROUGH THE LESION WITHOUT RESISTANCE. WHILE POSITIONING, HE ATTEMPTED TO PULL THE WIRE BACK AND NOTED THAT ABOUT 3CM OF THE TIP DETACHED AND REMAINED IN THE LESION. NO ATTEMPT WAS MADE TO RETRIEVE THE DETACHED PORTION. A 180CM 0.035" NON-BSC GUIDE WIRE WAS USED TO REACCESS THE LESION AND 2 EXPRESS LD STENTS WERE DEPLOYED ALONG WITH POST DILATION WHICH SUCCESSFULLY SECURED THE DETACHED GUIDE WIRE TIP AGAINST THE VESSEL WALL. THE FINAL OUTCOME WAS SUCCESSFUL AND THE PATIENT WAS STABLE POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STENTING TREATMENT PROCEDURE, GUIDE WIRE TIP DETACHMENT OCCURRED. ACCESS WAS GAINED VIA THE LEFT FEMORAL ARTERY. THE 80MM LONG AND ECCENTRIC DE NOVO TARGET LESION WAS LOCATED IN THE TOTALLY OCCLUDED, NON-TORTUOUS AND MODERATELY CALCIFIED LEFT COMMON FEMORAL ARTERY WITH A REFERENCE VESSEL DIAMETER OF 8MM. ACCESS WAS GAINED USING A 4F NON-BSC SHEATH WITH NO GUIDE CATHETER. A 185CM JOURNEY GUIDE WIRE WAS ADVANCED THROUGH THE LESION WITHOUT RESISTANCE. WHILE POSITIONING, HE ATTEMPTED TO PULL THE WIRE BACK AND NOTED THAT ABOUT 3CM OF THE TIP DETACHED AND REMAINED IN THE LESION. NO ATTEMPT WAS MADE TO RETRIEVE THE DETACHED PORTION. A 180CM 0.035" NON-BSC GUIDE WIRE WAS USED TO REACCESS THE LESION AND 2 EXPRESS LD STENTS WERE DEPLOYED ALONG WITH POST DILATION WHICH SUCCESSFULLY SECURED THE DETACHED GUIDE WIRE TIP AGAINST THE VESSEL WALL. THE FINAL OUTCOME WAS SUCCESSFUL AND THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001391260 13898122

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention ST. JUDE 4F SHEATH