BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 7882484 · Received September 17, 2018

    Report

    Report Number
    1820334-2018-02717
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    August 28, 2018
    Report Date
    November 30, 2018
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    10827002341989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: A REVIEW OF THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED RETRACTA MICROCOIL WAS RETURNED FOR INVESTIGATION. THE COIL WAS STILL ATTACHED TO THE DELIVERY WIRE AND THE TRANSITION FROM DELIVERY WIRE TO MICROCOIL APPEARED TO FOLLOW SPECIFICATIONS. AT THE DISTAL TIP OF THE DELIVERY WIRE, THE ATTACHED MICROCOIL APPEARED TO BE SLIGHTLY ELONGATED. THIS ELONGATION COULD BE A RESULT OF THE COIL BECOMING LODGED IN THE CATHETER AND THE PHYSICIAN PULLING THE COIL OUT. THE WELD BALL WAS INTACT AND CENTERED, AND NO OTHER DAMAGE WAS NOTED TO THE COIL. DUE TO THE MICROCOIL STILL BEING ATTACHED TO THE DELIVERY WIRE, THE COMPLAINT DESCRIPTION HAS BEEN CHANGED FROM ¿COILS DETACHED WHILE IN CATHETER¿ TO ¿COIL BECAME LODGED IN CATHETER¿. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS CONDUCTED. THE INSTRUCTIONS FOR USE (IFU) INSTRUCT THE USER TO ADVANCE THE WIRE SLOWLY TO ALLOW THE JUNCTION TO BE SEEN MORE EASILY IN ORDER TO REDUCE THE RISK OF DAMAGING IT. IT ALSO NOTED THAT IF SIGNIFICANT RESISTANCE IS ENCOUNTERED DURING COIL ADVANCEMENT, ADVANCEMENT SHOULD NOT CONTINUE. THE USER SHOULD RETRACT THE DELIVERY WIRE SLIGHTLY, THEN GENTLY RE-ADVANCE. IF SIGNIFICANT RESISTANCE IS STILL FELT, THE DELIVERY WIRE SHOULD BE WITHDRAWN FROM THE CATHETER AND A NEW COIL WITH A SHORTER LENGTH SHOULD BE USED. THE DELIVERY WIRE SHOULD NOT BE TURNED COUNTERCLOCKWISE DURING ADVANCEMENT, AS THE COIL MAY UNINTENTIONALLY DETACH. THE USER IS ALSO INSTRUCTED TO INSPECT THE PRODUCT PRIOR TO USE TO ENSURE THAT NO DAMAGE HAS OCCURRED. ADDITIONAL PRECAUTIONS DETAILED IN THE INSTRUCTIONS FOR USE (IFU) NOTE THAT PRIOR TO INTRODUCTION OF THE EMBOLIZATION COIL, THE ANGIOGRAPHIC CATHETER MUST BE FLUSHED WITH SALINE. THE PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN ARTERIAL AND VENOUS VESSEL EMBOLIZATION TECHNIQUES. STANDARD TECHNIQUES FOR PLACEMENT OF VASCULAR ACCESS SHEATHS, ANGIOGRAPHIC CATHETERS AND WIRE GUIDES SHOULD BE EMPLOYED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED ONE RELEVANT NONCONFORMANCE IN LOT 7130984 FOR COIL SEPARATION, IN WHICH ONE AFFECTED PIECE WAS REWORKED. IT SHOULD BE NOTED THAT THERE WAS ONE OTHER COMPLAINT ASSOCIATED WITH THIS LOT NUMBER FOR DIFFICULT DEPLOYMENT. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. THE COIL WAS STILL CONNECTED TO THE DELIVERY WIRE AND PASSED DIMENSIONAL, VISUAL AND FUNCTIONAL SPECIFICATIONS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE 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 NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    OCCUPATION: IR ORDERING. 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 RETRACTA DETACHABLE EMBOLIZATION COILS WERE USED DURING A BILIARY COILING PROCEDURE. IT WAS NOTED THAT TWO COILS DETACHED AS THEY WERE PUSHED THROUGH THE CATHETER. ONE COIL BUNCHED UP AT THE HUB OF THE CATHETER, WHILE THE OTHER WAS ASPIRATED BACK OUT OF THE CATHETER. THE COILS WERE THEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH TWO COILS OF A DIFFERENT TYPE. THIS REPORT REFERENCES ONE DETACHED COIL, WHILE MEDWATCH 1820334-2018-02745 REFERENCES THE OTHER DETACHED COIL USED DURING THE PROCEDURE. 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
    721679 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A 7130984 10827002341989

    Patients

    Seq Age Sex Outcome Treatment
    1 HNBR5.0-35-65-P-NS-KMP