BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY GUIDEWIRE

    MDR report key: 2024147 · Received March 18, 2011

    Report

    Report Number
    2134265-2011-00815
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 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

    AGE AT TIME OF EVENT: (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: ANALYSIS REVEALED THE DISTAL TIP, INCLUDING COIL WIRE/CORE WIRE/RIBBON (CCR JOINT) WAS NOT RETURNED FOR ANALYSIS. A SMALL PORTION WAS CUT BACK TO REVEAL THE CORE WIRE. THE CORE WIRE WAS FRACTURED. ANALYTICAL TEST RESULTS CONCLUDED THAT THE FRACTURE SURFACE APPEARED FLAT WHICH INDICATES THAT THE CORE WIRE FAILED BY TORSIONAL OVERLOAD. 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, A GUIDE WIRE SHEARED OFF AND REMAINED BEHIND IN THE PATIENT. THE 100% STENOSED AND CHRONIC TOTAL OCCLUSION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL LOCATED BELOW THE KNEE. A JOURNEY GUIDE WIRE WAS ADVANCED FOR TREATMENT BUT KINKED DURING THE PROCEDURE. APPROXIMATELY 1 CM OF THE DISTAL TIP OF THE GUIDE WIRE "SHEARED" OFF INSIDE OF THE PATIENT. AN UNSUCCESSFUL ATTEMPT TO REMOVE THE TIP WAS MADE. A NON BSC 2.5X18MM STENT WAS USED TO TRAP THE TIP OF THE GUIDE WIRE AGAINST THE VESSEL WALL BELOW THE KNEE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A GUIDE WIRE SHEARED OFF AND REMAINED BEHIND IN THE PATIENT. THE 100% STENOSED AND CHRONIC TOTAL OCCLUSION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL LOCATED BELOW THE KNEE. A JOURNEY GUIDE WIRE WAS ADVANCED FOR TREATMENT BUT KINKED DURING THE PROCEDURE. APPROXIMATELY 1 CM OF THE DISTAL TIP OF THE GUIDE WIRE "SHEARED" OFF INSIDE OF THE PATIENT. AN UNSUCCESSFUL ATTEMPT TO REMOVE THE TIP WAS MADE. A NON BSC 2.5X18MM STENT WAS USED TO TRAP THE TIP OF THE GUIDE WIRE AGAINST THE VESSEL WALL BELOW THE KNEE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001391260 13854513

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention