BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAINLESS STEEL EMBOLIZATION COIL

    MDR report key: 6816225 · Received August 24, 2017

    Report

    Report Number
    1820334-2017-02541
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    August 10, 2017
    Report Date
    December 1, 2017
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    10827002044330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PMA/510(K): K150931. ONE DEVICE COMPONENT WAS RETURNED TO THE MANUFACTURER. INVESTIGATION- SUMMARY: A REVIEW OF DOCUMENTATION, INSTRUCTIONS FOR USE, COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL DATA, PHOTOGRAPHIC INSPECTION, AND VISUAL INSPECTION WAS CONDUCTED DURING THE INVESTIGATION. TWO OPENED SHIPPING CANNULAS FROM LOT 4658872 WERE RETURNED. A WORKING STYLET WAS INSERTED INTO EACH CANNULA AND IT WAS FOUND THAT THERE WAS NOTHING INSIDE OF EITHER SHIPPING CANNULA. NO EMBOLIZATION COIL OR SEGMENTS OF COIL WERE RETURNED FOR EVALUATION. THEREFORE, NO DIMENSIONAL OR FUNCTIONAL TESTING OF THE COMPLAINT PRODUCT COULD BE COMPLETED. IN ADDITION, THERE WERE SEVERAL IMAGES OF THE COMPLAINT DEVICE INCLUDED WITH THE COMPLAINT FORM BY THE CUSTOMER. FROM THE IMAGES, THE EMBOLIZATION COIL IS DAMAGED AND SEPARATED INTO TWO PIECES. THE LARGER PIECE IS PARTIALLY CURLED ON ONE END, BUT THE MAJORITY OF THE COIL IS STRAIGHTENED. IT IS LIKELY THAT THE DEVICE SEPARATED AT THE JUNCTION BETWEEN THE MAIN COIL AND THE END COIL, BUT CAN NOT BE STATED DEFINITIVELY BASED ON THE PROVIDED IMAGES. THIS COMPLAINT WILL BE RE-EVALUATED IF ANY ADDITIONAL INFORMATION OR PRODUCT IS RECEIVED . THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED. NO RELATED NON-CONFORMANCES WERE REPORTED. A THOROUGH REVIEW OF COMPLAINT HISTORY SEARCH REVEALED THAT THIS IS THE ONLY RECORDED COMPLAINT ASSOCIATED WITH THIS LOT NUMBER. WITHOUT VISUAL INSPECTION OF THE AFFECTED PRODUCT OR ADDITIONAL INFORMATION FROM THE CUSTOMER, WE ARE UNABLE TO DETERMINE WITH CERTAINTY WHAT LED TO THE FAILURE MODE. THE ROOT CAUSE IS UNKNOWN AND NO CONCLUSION CAN BE DRAWN. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    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 INTERNATIONAL CUSTOMER REPORTED THAT, PRIOR TO THE EXCISION OF RIGHT LUNG NODULES, THE PHYSICIAN DELIVERED THE STAINLESS STEEL EMBOLIZATION COIL FOR A PREOPERATIVE LOCALIZATION. WHEN THE PHYSICIAN WITHDREW THE SHEATH, IT WAS DISCOVERED THAT THE COIL WAS BROKEN INSIDE OF IT. THE PHYSICIAN WITHDREW THE COIL AND THE SHEATH TOGETHER. IT WAS LATER CONFIRMED VIA THORACIC CT SCANNING THAT NO FRAGMENTS OF THE COIL HAD REMAINED IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598612 STAINLESS STEEL EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A 10827002044330

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR