BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST WIRE GUIDE

    MDR report key: 21166116 · Received January 16, 2025

    Report

    Report Number
    3002808486-2025-00010
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    March 11, 2024
    Report Date
    March 21, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR THIS CN# IS NO LONGER REPORTABLE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K220137. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: COMPRESSION CAUSED BY THE EXTRA-STIFF WIRE GUIDE DURING OFF-LABEL USE IN THE LEFT VENTRICULAR APEX. THE WIRE CIRCLE COMPRESSED THE LEFT VENTRICULAR ANGIOGRAPH APEX DURING SUCCESSFUL DEPLOYMENT OF A 29MM BALLOON-EXPANDABLE VALVE. LEFT VENTRICULAR ANGIOGRAPHY IMMEDIATELY AFTER PROCEDURE DEMONSTRATED SMALL LEFT VENTRICULAR ANEURYSM. 3 HOURS LATER THE PATIENT SUFFERED FROM CHEST PAIN AND ELECTROCARDIOGRAPHY SHOWED AN ELEVATION OF THE ST-SEGMENT. ANGIOGRAPHY OF THE LEFT VENTRICLE SHOWED A LARGE APICAL ANEURYSM AND TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED AN ANEURYSM AT THE APEX OF LEFT VENTRICLE WITH RUPTURE OF ENDOCARDIUM AND MYOCARDIUM. PATIENT OUTCOME: WIRE CAUSED COMPRESSION DURING OFF-LABEL USE IN LEFT VENTRICULAR APEX. FOLLOW-UP AFTER ONE MONTH SHOWED STABILITY OF THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953808 LUNDERQUIST WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male