BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRD DEVICE, EMBOLIZATION, VASCULAR

    MDR report key: 8787521 · Received July 14, 2019

    Report

    Report Number
    1820334-2019-01680
    Event Type
    Injury
    Date Received
    July 14, 2019
    Report Date
    September 9, 2019
    Manufacturer
    COOK INC
    Product Code
    KRD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION/EVALUATION A REVIEW OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL AND SPECIFICATIONS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THE FAILURE MODE PRIOR TO RELEASE. THIS ANALYSIS INDICATES THAT THE RISKS ASSOCIATED WITH THE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: "POSITIONING OF THE EMBOLIZATION COILS SHOULD BE DONE WITH PARTICULAR CARE. COILS SHOULD NOT BE LEFT TOO CLOSE TO THE INLETS OF ARTERIES AND SHOULD BE INTERMESHED WITH PREVIOUSLY PLACED COILS IF POSSIBLE. A MINIMAL BUT SUFFICIENT ARTERIAL BLOOD FLOW SHOULD REMAIN TO HOLD THE COILS AGAINST THE PREVIOUSLY PLACED COILS UNTIL A SOLID CLOT ENSURES PERMANENT FIXATION. THE PURPOSE OF THESE SUGGESTIONS IS TO MINIMIZE THE POSSIBILITY OF LOOSE COILS BECOMING DISLODGED AND OBSTRUCTION A NORMAL AND ESSENTIAL ARTERIAL CHANNEL." PRECAUTIONS: "PERFORM AN ANGIOGRAM PRIOR TO EMBOLIZATION TO DETERMINE CORRECT CATHETER POSITION." INSTRUCTIONS FOR USE: "6. PERFORM A FINAL ANGIOGRAM TO CONFIRM COIL POSITION WITHIN TARGET VESSEL." HOW SUPPLIED: "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED". BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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

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

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: PRODUCT INFORMATION CURRENTLY UNAVAILABLE. CUSTOMER/REPORTER INFORMATION CURRENTLY UNAVAILABLE. PMA/510(K) #: PRODUCT INFORMATION UNKNOWN. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. [MW5087393 (B)(4)].

    Description of Event or Problem · 1

    A MEDWATCH REPORT (SUS 3500A) FORM WAS RECEIVED FROM THE FDA REGARDING AN UNSPECIFIED COOK NESTER EMBOLIZATION COIL. AS REPORTED, "COIL PLACED FROM EMBOLIZATION CAUSED A PERFORATED URETER TUBE, ALLERGIC REACTION AND RESULTED IN KIDNEY TRANSPLANT." NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581301 KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R