BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY GUIDEWIRE

    MDR report key: 1963031 · Received January 18, 2011

    Report

    Report Number
    2134265-2010-05886
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THIS WAS A MULTI VESSEL INTERVENTION. THE DE NOVO LESION WAS LOCATED IN THE MILDLY TORTUOUS AND VERY CALCIFIED PERONEAL TIBIAL TRUNK. A NON-BSC INTRODUCER SHEATH WAS INSERTED CONTRA LATERAL TO THE TARGET LESION. NEXT THE STR, 300CM JOURNEY GUIDE WAS SELECTED AND DURING ADVANCEMENT DIFFICULTY CROSSING THE LESION WAS ENCOUNTERED. THE PHYSICIAN THEN SELECTED A NON-BSC PLAQUE EXCISION CATHETER AND WHILE ADVANCING AND POSITIONING THE GUIDE WIRE AND CATHETER USING SOME FORCE, THE JOURNEY GUIDE WIRE AND THE NON-BSC CATHETER FRACTURED PROXIMALLY. AN ATTEMPT TO RETRIEVE WAS MADE BY REMOVING THE PROXIMAL SECTION OF THE JOURNEY GUIDE WIRE FIRST AND THEN CUTTING THE HUB OF THE NON-BSC CATHETER TO REMOVE THE SHEATH, FOLLOWED BY THE FRACTURED PORTIONS OF THE NON-BSC CATHETER. THE SHEATH WAS REPLACED WITH AN UNSPECIFIED 8FR SHEATH THAT WAS ADVANCED TO THE REMAINING PORTION OF THE JOURNEY GUIDE WIRE. AFTER, THE REMAINING PORTION OF THE JOURNEY GUIDE WIRE WAS PROLAPSED INTO THE 8FR SHEATH AND BOTH DEVICES WERE WITHDRAWN TOGETHER. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. TWO DAYS POST PROCEDURE THE PATIENT RETURNED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001391280 13827996

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SHEATH, 90 SHUTTLE| PLAQUE EXCISION CATHETER, SILVER HAWK