BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 9537773 · Received January 2, 2020

    Report

    Report Number
    1820334-2020-00006
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 18, 2019
    Report Date
    March 5, 2020
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    10827002342047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL COULD NOT BE DEPLOYED. FURTHER COMMUNICATION WITH THE USER FACILITY CLARIFIED THAT THESE COILS WERE ATTEMPTED TO BE RELEASED INTO A 5.0FR BEACON TIP CATHETER DURING EMBOLIZATION OF A PERCUTANEOUS PSEUDOANEURYSM. COOK BECAME AWARE OF THIS EVENT UPON BEING NOTIFIED BY A DOCTOR FROM (B)(6) HOSPITAL. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH TWO NESTER COILS AND TWO INTERLOCK COILS. THE PATIENT REPORTEDLY EXPERIENCED NO ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED SO A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. SINCE RELEVANT DIMENSIONS COULD NOT BE MEASURED AGAINST SPECIFICATION, IT WAS CONCLUDED THE DEVICE WAS MANUFACTURED WITHIN SPECIFICATION. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. THERE IS EVIDENCE OF TESTING IN PLACE TO MEET DESIGN REQUIREMENTS RELATED TO THIS FAILURE MODE. PRODUCT LABELING WAS ALSO REVIEWED. INSTRUCTIONS FOR USE ARE PACKAGED WITH THIS DEVICE. RELEVANT SECTIONS INCLUDE: PRECAUTIONS. PRIOR TO INTRODUCTION OF THE EMBOLIZATION COIL, FLUSH THE ANGIOGRAPHIC CATHETER WITH SALINE. INSTRUCTIONS FOR USE: 8. IF COIL POSITION IS CORRECT, USE THE TORQUE DRIVER DEVICE TO TURN THE DELIVERY WIRE COUNTERCLOCKWISE 8-10 TIMES, UNTIL COIL DETACHMENT CAN BE EITHER FELT OR VISUALIZED UNDER FLUOROSCOPY. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT SHOWED NO RELATED NONCONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS FROM THE LOT AT THE TIME OF THE INVESTIGATION. SINCE THERE ARE NO RELATED NONCONFORMANCES OR OTHER COMPLAINTS FROM THIS LOT, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. IT IS POSSIBLE THAT USE ERROR CONTRIBUTED TO THE FAILURE SINCE THE IFU STATES TO FLUSH THE CATHETER WITH SALINE PRIOR INTRODUCTION OF THE COIL, AND THE CUSTOMER DID NOT FLUSH THE CATHETER. HOWEVER, THE INCREASED FRICTION DUE TO NOT FLUSHING THE CATHETER MAY ACTUALLY MAKE IT EASIER TO RELEASE THE COIL. IT IS ALSO POSSIBLE THAT THE USER WAS ROTATING THE COIL THE WRONG DIRECTION (CLOCKWISE). HOWEVER, BOTH OF THESE USE ERROR POSSIBILITIES CANNOT BE DEFINITIVELY CONFIRMED WITHOUT PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE OR ADDITIONAL INFORMATION. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THE FAILURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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

    CONCOMITANT MEDICAL PRODUCTS: COOK 5.0 FR KMP BEACON TIP CATHETER. 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 MALE PATIENT REQUIRED PLACEMENT OF A RETRACTA DETACHABLE EMBOLIZATION COIL DURING A PERCUTANEOUS EMBOLIZATION PROCEDURE FOR A PSEUDOANEURYSM OF A HEPATIC ARTERY. AFTER THE COIL WAS ADVANCED IN A 5.0 FR KMP BEACON TIP CATHETER, "THE COILS WOULD NOT DETACHED FORM THE WIRE." THE OPERATOR SUCCESSFULLY COMPLETED THE PROCEDURE USING A COMBINATION OF NESTER COILS AND COILS OF ANOTHER MANUFACTURER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3089 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A 9780627 10827002342047

    Patients

    Seq Age Sex Outcome Treatment
    1