BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 7081658 · Received December 4, 2017

    Report

    Report Number
    1820334-2017-04232
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    November 9, 2017
    Report Date
    December 14, 2017
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    10827002341873
    PMA / PMN Number
    K123712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATION COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THE DEVICE HISTORY RECORD (LOT NUMBER 7020574 AND RELEVANT SUBASSEMBLY LOT NUMBERS) WAS REVIEWED AND DETERMINED THAT NO NONCONFORMANCE'S WERE RECORDED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. A SEARCH OF OUR COMPLAINT RECORDS CONFIRMED THIS COMPLAINT TO BE THE ONLY REPORTED COMPLAINT FOR THE LOT. THE DEVICE IS THOROUGHLY INSPECTED DURING QUALITY CONTROL INSPECTION FOR DIMENSIONAL AND VISUAL CRITERIA. RISK DOCUMENTATION IS IN PLACE THAT IDENTIFIES THE FAILURE MODE RELATED TO PREMATURE DETACHMENT OF THE COIL. THERE IS NO EVIDENCE THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION. THE REP REPORTED THAT DURING A DEMO, WHEN THE DELIVERY WIRE WAS PUSHED OUT OF THE METAL CANNULA PRESUMABLY TO SHOW THE EMBOLIZATION COIL, THE COIL DETACHED FROM THE WIRE. THE DEVICE IS INTENDED TO BE TRANSFERRED FROM THE METAL CANNULA INTO A CATHETER. THE CATHETER PROVIDES STABILITY AND SECUREMENT TO THE COIL/DELIVERY WIRE JUNCTION. THE IFU STATES THAT THE JUNCTION BETWEEN THE COIL AND THE DELIVERY WIRE SHOULD REMAIN INSIDE THE CATHETER. IT IS LIKELY THAT THE JUNCTION WAS UNSUPPORTED DURING THE DEMONSTRATION, ALLOWING THE COIL TO DETACH FROM THE DELIVERY WIRE, OR THAT THE WIRE WAS INADVERTENTLY TURNED WHILE PUSHING THE DELIVERY WIRE THROUGH THE CANNULA. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION; THE ROOT CAUSE WAS DETERMINED TO BE RELATED TO PRODUCT USE AND HANDLING, THE OPERATIONAL CONTEXT IN WHICH IT WAS USED (DEMONSTRATION). A RISK ASSESSMENT WAS NOT PERFORMED AS THIS EVENT HAD NO PATIENT-RELATED IMPLICATIONS AND THE DEVICE WAS LIKELY USED OUTSIDE OF ITS INTENDED DESIGN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, DURING A PRODUCT DEMONSTRATION, UPON THE OPENING OF THE RETRACTA DETACHABLE EMBOLIZATION COIL, THE COIL DETACHED FROM THE DELIVERY WIRE AS THE WIRE WAS PUSHED OUT OF THE METAL CANNULA FOR THE FIRST TIME. THE WIRE WAS REPORTEDLY NOT TORQUED, AND THE COILS WERE NOT HELD ON TO WHILE THE WIRE WAS ADVANCED. THE CUSTOMER CONFIRMED THAT THE DEVICE WAS NOT USED; ACCORDINGLY, NO PATIENT ADVERSE EVENTS OCCURRED AS A RESULT OF THE PRODUCT ISSUE. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860783 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A 10827002341873

    Patients

    Seq Age Sex Outcome Treatment
    1