BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE 0.018 4/320CM ANGLED (STRAUB MEDICAL)

    MDR report key: 10791442 · Received November 5, 2020

    Report

    Report Number
    3008439199-2020-00053
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 6, 2020
    Report Date
    October 7, 2020
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    DQX
    UDI-DI
    07640142810261
    PMA / PMN Number
    K172315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS DISCARDED AT THE HOSPITAL. INVESTIGATION WAS PERFORMED WITHOUT THE DEVICE.

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE NOT RETURNED YET. THE RETURN OF SUSPECT DEVICE IS EXPECTED. FURTHER INFORMATION ABOUT SET ROTAREXS 6F 135CM: CATALOGUE NUMBER: 80237, LOT NUMBER: 200664, EXPIRATION DATE (MM/DD/YYY): 04/30/2023, UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4).

    Description of Event or Problem · 1

    STRAIGHT FORWARD CASE. 6F 45 CM FLEX ANSEL UP AND OVER SHEATH WAS USED. A .018 STAUB WIRE ADVANCED ONCE ROTAREX USAGE DETERMINED. ROTAREX 6F 135 REF #(B)(4) LOT# 200541 PRESENTED FOR ISR AND IN BETWEEN THE 2 SFA/POP STENTS. DOC AWARE OF OFF LABEL INDICATION. DR. CARTER TREATED THE 2 STENTS AND THE GAP IN BETWEEN STENTS. DURING PROCEDURE THE ROTAREX CLUTCHED OUT ONE TIME, DOC BACKED UP AND REENGAGED LESION. TERRIFIC RESULTS. REMOVED ROTAREX AND INSPECTED. INTACT. UPON INTRODUCING AN ULTRAVERSE 5X150 PTA, PTA WOULDN'T ADVANCE. NOTICED THE PROXIMAL TIP OF WIRE HAD FRACTURED. THE FRACTURED PORTION OF THE PROXIMAL 30CM PORTION OF WIRE WAS IN THE PROXIMAL SFA. PHYSICIAN SNARED WIRE PORTION WITH NO COMPLICATION. CASE WAS COMPLETED WITH .035 WIRE, PTA AND STENTING. EXCELLENT RESULT. PHYSICIAN SAID ABSOLUTELY NO ISSUE WITH DEVICE. COMLAINED IS GUIDEWIRE WHICH IS PART OF SET ROTAREXS 6F 135CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254808 GUIDEWIRE 0.018 4/320CM ANGLED (STRAUB MEDICAL) WIRE, GUIDE, CATHETER DQX STRAUB MEDICAL AG GUIDEWIRE 0.018 4/320CM ANGLED 200600 07640142810261

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention