BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY GUIDEWIRE

    MDR report key: 1933364 · Received December 20, 2010

    Report

    Report Number
    2134265-2010-05518
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR, EVALUATION SUMMARY ATTACHED: UPDATED METHOD, RESULTS, AND CONCLUSION: UPDATED. DEVICE EVALUATION BY MANUFACTURER: THE GUIDEWIRE WAS RETURNED FRACTURED. THE HIGH TORQUE SLEEVE (HTS) MEASURED APPROXIMATELY 6.25 IN, WHICH INDICATES THAT APPROXIMATELY .75 IN OF THE DISTAL TIP INCLUDING THE COIL WIRE/CORE WIRE/RIBBON JOINT WERE DETACHED/SEPARATED FROM THE GUIDEWIRE AND NOT RETURNED FOR PRODUCT ANALYSIS. A SMALL PORTION OF THE HTS WAS REMOVED TO EXPOSE THE COREWIRE. MICROSCOPIC INSPECTION REVEALED A COREWIRE FRACTURE. ANALYTICAL TESTING CONCLUDED THAT THERE WAS BENDING IN THE AREA OF WHERE THE FRACTURE OCCURED. THERE IS EVIDENCE THAT THE COREWIRE FRACTURE WAS DUE TO TWISTING OF THE GUIDEWIRE AND THEN PULLED TO FAILURE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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 A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. THE TIP OF THE JOURNEY GUIDE WIRE WAS BENT AND DETACHED. THE TIP REMAINED IN THE PROXIMAL TIBIAL ARTERY. THE TIP WAS STENTED TO THE VESSEL WALL WITH A NON BSC STENT. THE PROCEDURE WAS COMPLETED WITH A V18 GUIDE WIRE. NO FURTHER PATIENT INJURIES WERE REPORTED. THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. THE TIP OF THE JOURNEY GUIDE WIRE WAS BENT AND DETACHED. THE TIP REMAINED IN THE PROXIMAL TIBIAL ARTERY. THE TIP WAS STENTED TO THE VESSEL WALL WITH A NON BSC STENT. THE PROCEDURE WAS COMPLETED WITH A V18 GUIDE WIRE. NO FURTHER PATIENT INJURIES WERE REPORTED. THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001391280 0013778113

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention