BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER NS GUIDE WIRE

    MDR report key: 7323243 · Received March 2, 2018

    Report

    Report Number
    MW5075754
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    December 19, 2017
    Report Date
    January 16, 2018
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017 AT 12:00 IN GSH CATH LAB 1 WE HAD A STEMI WITH DR (B)(6) ((B)(6) 2017 AT 1141). DR (B)(6) USED AN 0.014" WHISPER MS WIRE TO DELIVER THE APPROPRIATE BALLOONS AND STENTS TO OPEN UP A BLOCKED RIGHT CORONARY ARTERY. DURING THE STEMI, THE TIP OF THE WIRE BECAME UNCOILED, YET STAYED INTACT. WE DID NOT LOSE ANY OF THE WIRE IN THE PT'S BODY. DUE TO THE WIRE COMING APART, DR (B)(6) HAD TO REMOVE THE DEFECTIVE EQUIPMENT AND REPLACE IT. THIS ADDED UNNECESSARY TIME AND RISK TO THE STEMI PT AND EFFECTED THE TIMELINESS OF CARE. REF MFR# 2024168-2018-01527.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152049 HI-TORQUE WHISPER NS GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR 7072671

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR