BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 13281785 · Received January 18, 2022

    Report

    Report Number
    1820334-2022-00073
    Event Type
    Death
    Date Received
    January 18, 2022
    Date of Event
    October 15, 2021
    Report Date
    May 9, 2022
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. COMMON NAME & PRODUCT CODE: UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INFORMATION WAS RECEIVED FROM THE PHYSICIAN ON 05MAY2022 THAT THE WIRE GUIDE INVOLVED IN THIS EVENT WAS NOT MANUFACTURED BY COOK, INC. BECAUSE THERE HAS BEEN NO ALLEGATION OF ANY MALFUNCTION OR INVOLVEMENT OF ANY COOK DEVICE DURING THE PROCEDURE, THIS EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    AS REPORTED TO COOK BY ANOTHER DEVICE MANUFACTURER (REFERENCE (B)(4)), DURING A PROCEDURE INVOLVING A PATIENT WITH ATRIAL FIBRILLATION, AN UNSPECIFIED COOK WIRE ALLEGEDLY CAUSED A TEAR IN A VESSEL, LEADING TO THE PATIENT¿S DEATH. COMPLICATIONS WERE REPORTED AT THE GROIN SITE DUE TO AN UNKNOWN KINKED WIRE (IT IS UNKNOWN IF THIS WIRE WAS MANUFACTURED BY COOK AND IF THIS IS THE SAME WIRE THAT REPORTEDLY CAUSED A VESSEL TEAR). REPORTEDLY, THE IMAGE ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS UNSATISFACTORY. ANOTHER ICE CATHETER WAS USED TO CONTINUE THE PROCEDURE; HOWEVER, THE PATIENT EXPIRED FROM ¿SOME SORT OF TEAR IN THE VESSELS FROM THE (NON-ABBOTT) WIRE¿. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. PER THE PHYSICIAN, THE WIRE INVOLVED IN THIS EVENT WAS NOT MANUFACTURED BY COOK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216164 UNKNOWN WIRE DQX COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death