BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXT DETACHABLE COIL, HELIX STANDARD

    MDR report key: 743819 · Received June 24, 2005

    Report

    Report Number
    2029214-2005-00043
    Event Type
    Injury
    Date Received
    June 24, 2005
    Date of Event
    May 20, 2005
    Report Date
    June 24, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED UNIT HAS A GUIDEWIRE, MARKER COIL, AND DETACH WIRE. THE DETACH WIRE MEASURES 0.83MM IN LENGTH. THE PROXIMAL PART OF THE DETACH WIRE IS LIGHTER IN COLOR THAN THE DISTAL PART. THE LIGHTER COLORED PORTION MEASURES 0.32MM IN LENGTH, WHICH IS WITHIN TOLERANCE FOR LENGTH OF THE DETACHMENT ZONE. THE DARKER PORTION MEASURES 0.51MM IN LENGTH, WHICH IS WITHIN TOLERANCE FOR THE LENGTH OF THE COIL SHELL. THE DARKER COLOR IS INDICATIVE OF CONTACT WITH HEAT DURING THE WELDING PROCESS. THE DISTAL BALL IS VERY SMALL ON THE RETURNED PART. EITHER THE BALL WAS NOT FORMED OR IT WAS CONSUMED WHEN WELDING THE IMPLANT TO THE COIL SHELL. THE REVIEW OF THE LOT HISTORY RECORD DEMONSTRATED THAT THE LOT WAS IN CONFORMANCE WITH ALL DIMENSIONAL INSPECTIONS, AND TESTING. BASED ON THE INITIAL REPORT, PHYSICAL EVALUATION, AND THE COMPLAINT PRODUCT LOT HISTORY, A DEFINITIVE CONCLUSION CANNOT BE MADE. THE WELD THAT ATTACHES THE COIL SHELL TO THE DETACH WIRE IS VISUALLY INSPECTED AND IS TESTED FOR TENSILE STRENGTH 100% DURING PRODUCTION, THUS THIS WELD SHOULD BE ABLE TO WITHSTAND CLINICAL USE FORCES BETWEEN 90 TO 100G. EITHER THE WELD WAS COMPROMISED DURING TRANSPORT OR TESTING, OR IT WAS EXPOSED TO FORCES GREATER THAN 100G DURING USE.

    Description of Event or Problem · 1

    THIS WAS A RECOILING OF AN INTER CAVERNOUS ANEURYSM USING THE NXT COILS. THE ANEURYSM WAS APPROXIMATELY 8MM IN SIZE AND HAD A 5-6MM NECK. TWO COILS WERE PLACED IN THIS ANEURYSM AND STASIS WAS ACHIEVED USING APPROXIMATELY 30 CM OF COIL. THE PROCEDURE WAS STOPPED KNOWING THAT RECOIL MIGHT BE NEEDED AT A LATER TIME. THE PROCEDURE FOR RECOILING WAS DONE USING AN ECHELON 10 CATHETER AND A 4X20 HYPERGLIDE BALLOON. A 5 X 20 T18 COIL WAS SELECTED AND UPON PLACEMENT OF THE COIL, IT WAS OBSERVED THAT IT HAD BROKEN OFF IN THE ANEURYSM. THE BALLOON WAS DEFLATED AND 5 TO 6 LOOPS WERE OBSERVED IN THE PARENT ARTERY. SEVERAL OTHER MICROVENTION PLATINUM COILS WERE USED TO EMBOLIZE THE RESIDUAL AND PATIENT WAS BROUGHT TO ICU. PATIENT SLOW TO RESPOND COMING OUT OF ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXT DETACHABLE COIL, HELIX STANDARD ELECTROLYTICALLY DETACHABLE COIL HCG MICRO THERAPEUTICS, INC. N-5-20-T18 1127268

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening