BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 8367195 · Received February 25, 2019

    Report

    Report Number
    1820334-2019-00279
    Event Type
    Injury
    Date Received
    February 25, 2019
    Date of Event
    February 8, 2019
    Report Date
    March 27, 2019
    Manufacturer
    COOK INC
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. A REVIEW OF THE SPECIFICATIONS, DEVICE HISTORY RECORD, AND DOCUMENTATION WAS CONDUCTED DURING THE INVESTIGATION UPON A SEARCH OF ALL LOTS SOLD TO THE REPORTED CUSTOMER FOR THE REPORTED RPN DURING THE SHELF LIFE OF THE DEVICE, ONLY 2 DIFFERENT LOTS WERE FOUND; 7585505 AND 9110475. THE INVESTIGATION WILL CONTINUE WITH THIS INFORMATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED WITH THE ABOVE LOTS AND NO OTHER RELATED LOT COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. BECAUSE OF THIS, NO DIMENSIONAL, VISUAL, OR FUNCTIONAL VERIFICATIONS COULD BE COMPLETED. AT THIS TIME, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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

    PMA/510(K): K151676. (B)(4). 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 AN RETRACTA DETACHABLE EMBOLIZATION COIL WAS USED DURING EMBOLIZATION OF SEGMENTAL RENAL ARTERY. AS REPORTED BY THE USER ¿AFTER DETACHING THE COIL, IT WAS IMPOSSIBLE TO DETACH THE PUSHER WIRE AND IT WAS ALSO IMPOSSIBLE TO REMOVE THE COIL.¿ THE PATIENT REQUIRED OPEN SURGICAL PROCEDURE TO REMOVE THE COMPLAINT DEVICE. THE COMPLAINT DEVICE WAS REMOVED SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159148 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1