BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 8717549 · Received June 20, 2019

    Report

    Report Number
    1820334-2019-01492
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    June 14, 2019
    Report Date
    July 16, 2019
    Manufacturer
    COOK INC
    Product Code
    KRD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON REVIEW, THIS MEDWATCH REPORT AND MEDWATCH REPORT #1820334-2019-01605 RECORD THE SAME EVENT. FOLLOW UPS WILL NO LONGER BE SUBMITTED FOR THIS REPORT. ADDITIONAL INFORMATION AND THE INVESTIGATION WILL BE SUBMITTED UNDER MEDWATCH REPORT #1820334-2019-01605. THE INFORMATION IN MEDWATCH REPORT #1820334-2019-01605 HAS BEEN VERIFIED. 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.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #:K151676. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED A RETRACTA DETACHABLE EMBOLIZATION COIL WAS USED IN A (B)(6) YEAR OLD MALE PATIENT DURING AN EMBOLIZATION OF A VARICOCELE. THE REPORTER STATED THE PHYSICIAN USED 4 RETRACTA COILS. THREE OF THE COILS WERE DEPLOYED SUCCESSFULLY. AS REPORTED, "THE FOURTH RETRACTA COULDN`T BE DETACHED." THE USER ALSO EXPERIENCES DIFFICULTY PULLING BACK OF THE DEVICE IN THE CATHETER. THE DEVICE WAS SUCCESSFULLY REMOVED, HOWEVER A PORTION OF THE COIL DETACHED INTO THE VEIN. THE FRAGMENT WAS NOT REMOVED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509552 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other