BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DQX WIRE, GUIDE, CATHETER

    MDR report key: 12727533 · Received November 1, 2021

    Report

    Report Number
    3002808486-2021-01937
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    September 10, 2021
    Report Date
    February 7, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE GUIDE WIRE WAS USED FOR PLACEMENT OF A ZENITH DEVICE (B)(4) AND ONE WEEK AFTER THE PROCEDURE THE PATIENT PRESENTED WITH INFECTED AORTA. THE WIRE GUIDE WAS NOT RETURNED TO ASSIST THE INVESTIGATION AND WITHOUT THE ACTUAL COMPLAINT DEVICE BASED ON THE VERY LIMITED INFORMATION ONLY, IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE ¿INFECTED AORTA¿ ONE WEEK AFTER THE PROCEDURE, IN WHICH THE WIRE GUIDE WAS USED. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS TYPE OF DEVICE WAS MANUFACTURED TO SPECIFICATIONS. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. 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

    MANUFACTURER REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS LUNDERQUIST WIRE GUIDES. OCCUPATION: UNKNOWN. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: COMPLAINT FOR LUNDERQUIST WIRE IS OPENED RELATED TO ((B)(4), MANUFACTURER REF# 3002808486-2021-01835). ONE WEEK SUBSEQUENT TO CASE, PATIENT PRESENTED WITH INFECTED AORTA. MICROPUNCTURE, 260CM LUNDERQUIST WIRE, IVUS (INTRAVASCULAR ULTRASOUND) WAS USED DURING THE PROCEDURE. PATIENT OUTCOME: SUCCESSFUL CASE AND OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630073 DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Life Threatening