BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-18 CONTROL WIRE

    MDR report key: 9354406 · Received November 21, 2019

    Report

    Report Number
    2134265-2019-14193
    Event Type
    Injury
    Date Received
    November 21, 2019
    Date of Event
    October 21, 2019
    Report Date
    November 21, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729070207
    PMA / PMN Number
    K033742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORTED VIA MEDWATCH # (B)(4). IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND TIP DETACHMENT OCCURRED. THE PROCEDURE WAS A RIGHT LOWER EXTREMITY ANGIOGRAM AND RECANALIZATION OF OCCLUDED DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY (PPA). THE TARGET LESION WAS LOCATED IN THE DISTAL SFA AND PPA. WHILE CROSSING A 300CM, 8CM POLY TIP V-18 GUIDE WIRE, THE TIP BECAME STUCK IN THE POPLITEAL ARTERY WALL. THE TIP BROKE OFF AND REMAINED IN THE VESSEL WALL. NO ATTEMPT WAS MADE IN RETRIEVING THE TIP TO AVOID RISK FOR INJURY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152249 V-18 CONTROL WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 40495 0024144452 08714729070207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other