BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 7107993 · Received December 12, 2017

    Report

    Report Number
    1820334-2017-04360
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 22, 2017
    Report Date
    February 16, 2018
    Manufacturer
    COOK INC
    Product Code
    KRD
    PMA / PMN Number
    K123712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION : A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. A RETRACTA DETACHABLE EMBOLIZATION COIL WAS RETURNED IN AN OPENED, USED, AND DAMAGED CONDITION. A VISUAL EXAMINATION DISCOVERED THE PROXIMAL DELIVERY COIL WAS COMPLETELY ELONGATED. DUE TO THE CONDITION OF THE COIL, IT IS NOT POSSIBLE TO CONFIRM IS ANY OF THE COIL IS MISSING (BROKEN OFF). IT WAS ALSO DISCOVERED A SECTION OF THE DELIVERY WIRE LOCATED NEAR THE DISTAL TIP HAS SEPARATED MEASURING APPROXIMATELY 2.0CM IN LENGTH. THE DETERMINATION WAS MADE THAT BOTH THE PROXIMAL AND DISTAL DELIVERY COILS WERE ATTACHED TO THIS SEPARATED SECTION OF WIRE. THE OUTER DIAMETER OF THE PROXIMAL AND DISTAL DELIVERY WIRE COILS COULD NOT BE MEASURED DUE TO THE CONDITION OF THE COILS. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. NUMEROUS DESIGN VERIFICATION AND VALIDATION ACTIVITIES HAVE BEEN PERFORMED TO ENSURE THAT THIS DEVICE MEETS DESIGN REQUIREMENTS. ALTHOUGH THE LOT NUMBER FOR THIS DEVICE COULD NOT BE PROVIDED, A SEARCH USING THE PROVIDED CUSTOMER NUMBER DETERMINED THERE ARE ONLY TWO POSSIBLE LOTS FOR THIS COMPLAINT (7791675 OR 7829906), BOTH OF WHICH WERE REVIEWED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WAS ONE OTHER REPORTED COMPLAINT FOR LOT NUMBER 7829906. THE IFU INSTRUCTS TO ENSURE THE JUNCTION REMAINS POSITIONED INSIDE THE CATHETER TIP. AS ABOUT 7 COILS OF THE DISTAL DELIVERY COIL WERE CLOSE TOGETHER BEFORE THE REMAINING COILS BECAME ELONGATED, IT IS REASONABLE TO SUGGEST THIS PORTION OF THE DELIVERY WIRE BECAME CAUGHT ON THE OUTSIDE OF THE CATHETER, RESULTING IN THE COIL ELONGATION. IT IS UNCLEAR WHETHER THE COIL ELONGATED OR THE DELIVERY WIRE SEPARATED FIRST. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    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 THE RETRACTA DETACHABLE EMBOLIZATION COIL FAILED TO DETACH FROM THE DELIVERY WIRE, WHICH CAUSED THE COIL TO SNAP. THE REMAINING PORTION OF THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THE COIL REPORTEDLY DID NOT DETACH FROM THE INTENDED JUNCTION ZONE. THE CUSTOMER HAS CONFIRMED THAT NO PATIENT ADVERSE EVENTS OCCURRED, AND NO ADDITIONAL PROCEDURES WERE NECESSITATED BY THE PRODUCT MALFUNCTION. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888940 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1