BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 7882488 · Received September 17, 2018

    Report

    Report Number
    1820334-2018-02745
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    August 28, 2018
    Report Date
    November 20, 2018
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    10827002341880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: IR ORDERING. PMA/510(K) #: NOT EXEMPT, K151676. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    PRODUCT RECEIVED ON: 18 SEPTEMBER 2018. INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS RETURNED IN USED CONDITION FOR EVALUATION. THE CUSTOMER DID NOT RETURN THE COIL WITH THE DEVICE COMPONENTS, SO NO DIMENSIONAL OR FUNCTIONAL ANALYSIS COULD BE COMPLETED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS DETERMINED THAT THERE ARE SUFFICIENT CONTROLS IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO DEVICE RELEASE. A PRECAUTION NOTED IN THE INSTRUCTIONS FOR USE (IFU) STATES THAT PRIOR TO INTRODUCTION OF THE EMBOLIZATION COIL, THE USER MUST FLUSH THE CATHETER 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. OTHER NOTES REFERENCED IN THE IFU STATE THAT THE WIRE MUST BE ADVANCED SLOWLY TO ALLOW THE JUNCTION TO BE SEEN MORE EASILY TO REDUCE THE RISK OF DAMAGE. IF SIGNIFICANT RESISTANCE IS ENCOUNTERED DURING COIL ADVANCEMENT, ADVANCEMENT SHOULD BE DISCONTINUED AND THE WIRE SHOULD BE RETRACTED SLIGHTLY BEFORE TRYING TO RE-ADVANCE. IF THERE IS STILL SIGNIFICANT RESISTANCE, THE DELIVERY WIRE SHOULD BE WITHDRAWN AND A NEW COIL WITH A SHORTER LENGTH SHOULD BE USED.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 BE UNINTENTIONALLY DETACHED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED TWO NONCONFORMANCES WITHIN THE MAIN LOT FOR DISPLACEMENT IN THE PACKAGE AND FOR FOREIGN MATTER, ALL OF WHICH WERE REWORKED. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 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 1820334-2018-02717 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.

    Description of Event or Problem · 1

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721686 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC NA 7900883 10827002341880

    Patients

    Seq Age Sex Outcome Treatment
    1