BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 9074378 · Received September 17, 2019

    Report

    Report Number
    3002808486-2019-01486
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    September 3, 2019
    Report Date
    December 18, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002454088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR THIS PR# IS NO LONGER REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS REPORTED THAT THE WIRE GOT KINKED DURING EXCHANGE AND WAS REPLACED WITHOUT ANY ADVERSE EFFECTS TO THE PATIENT. NO PRODUCT WAS RETURNED AND NO IMAGING WAS PROVIDED TO ASSIST THE INVESTIGATION AND BASED ON THE INFORMATION RECEIVED IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE WIRE GUIDE TO KINK. HOWEVER, IT IS NOTED IT WAS LIKELY DUE TO SEVERE ANGULATION AT THE RIGHT EXTERNAL ILIAC ARTERY. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR 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.

    Additional Manufacturer Narrative · 1

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. SIMILAR TO DEVICE UNDER PMA/510(K) K171513. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: TEVAR WAS BEING PERFORMED WITH ANOTHER MANUFACTURER¿S STENT GRAFT. FIRST, A WIRE GUIDE (FROM ANOTHER MANUFACTURER) AND A CATHETER WERE ADVANCED TO THE AORTIC VALVE. THEN, THE PHYSICIAN ATTEMPTED TO EXCHANGE THE WIRE GUIDE FOR THE COMPLAINT (B)(4) WITH THE RIGHT APPROACH. HOWEVER, IT GOT KINKED LIKELY DUE TO THE SEVERE ANGULATION AT THE RIGHT EXTERNAL ILIAC ARTERY. AFTER THAT, ANOTHER (B)(4) WAS SUBSTITUTED FOR THE COMPLAINT ONE. THE SUBSTITUTE ONE COULD BE DELIVERED WITHOUT GETTING KINK. THE KINK DID NOT HAVE SHARP EDGES. PATIENT OUTCOME: NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868166 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G45408 E3857298 00827002454088

    Patients

    Seq Age Sex Outcome Treatment
    1