BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 20632154 · Received November 7, 2024

    Report

    Report Number
    3014162263-2024-00089
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 4, 2024
    Report Date
    November 7, 2024
    Manufacturer
    BALT USA
    Product Code
    HCG
    UDI-DI
    00818053025266
    PMA / PMN Number
    K200030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BALT USA REFERENCE#: (B)(4). THE RETURNED DEVICE WAS INSPECTED IN OUR QUALITY LABORATORY. DURING OUR ANALYSIS: WE OBSERVED ONLY THE IMPLANT COIL WAS INCLUDED WITH THE DEVICE RETURN WITHOUT THE INTRODUCER SHEATH AND DELIVERY PUSHER. WE OBSERVED MULTIPLE MINOR AND MAJOR KINKS AND STRETCHING ALONG THE IMPLANT COIL. WE OBSERVED THE SR THREAD OF THE IMPLANT COIL TO BE OPAQUE IN COLOR. WE OBSERVED THE RETURNED IMPLANT COIL WAS COVERED IN BLOOD. WE NOTED THE ASSOCIATED MICROCATHETER WAS NOT RETURNED WITH THE COIL SYSTEM. ROOT CAUSE OF THE REPORTED ISSUE ENDURED BY THE COIL SYSTEM CAN POSSIBLY BE ATTRIBUTED TO THE IMPLANT COIL BECOMING DAMAGED DURING THE REPOSITIONING OF THE IMPLANT COIL, RESULTING IN THE IMPLANT COIL BECOMING STRETCHED UPON RETRACTING THE COIL SYSTEM. UPON RETURN OF THE DEVICE, WE OBSERVED MULTIPLE MINOR AND MAJOR KINKS AND STRETCHING ALONG THE IMPLANT COIL AND WE OBSERVED THE SR THREAD OF THE IMPLANT COIL TO BE OPAQUE IN COLOR. IT WAS REPORTED THAT "WHILE REPOSITIONING THE OPTIMA IMPLANT COIL WITHIN THE ANEURYSM TO ACHIEVE THE DESIRED SHAPE, THE PHYSICIAN FOUND THAT THE COIL HAD STRETCHED". AS A SNARE DEVICE WAS UTILIZED TO RETRIEVE THE IMPLANT COIL, THE CONDITION OF THE RETURNED IMPLANT COIL SHOWED DAMAGE THROUGHOUT THE COIL. IT IS LIKELY THAT THE IMPLANT BECAME STRETCHED AFTER THE IMPLANT COIL ENCOUNTERED FRICTION, AND THE USER ATTEMPTED TO RETRACT THE COIL SYSTEM. WITHOUT THE RETURN OF THE DELIVERY PUSHER OR MICROCATHETER USED DURING THE INCIDENT, FURTHER ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE LHR INDICATED THAT THE UNIT WAS FREE FROM VISUAL DAMAGE, INCLUDING THE IMPLANT COIL AT THE POINT OF THE 100% FINAL INSPECTION. REVIEW OF THE LOT HISTORY RECORDS DID NOT REVEAL ANY IN-PROCESS OR LOT-SPECIFIC ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. NO ADDITIONAL COMPLAINTS AGAINST LOT NUMBER: F231001048 HAS BEEN MADE FOR THE SAME ISSUE. COMPREHENSIVE ANALYSIS OF THIS FAILURE MODE HAS REMAINED SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "PATIENT INFORMATION: SEX: UNKNOWN, DISEASE NAME: 10 MM ANEURYSM AT THE C2 PORTION OF THE IC, PROCEDURE: PLANNED PROCEDURE, MICRO CATHETER: GREACH/TOKAI MEDICAL PRODUCTS INC., PHENOM 17/MEDTRONIC, AND EXCELSIOR 1018/STRYKER, GUIDING CATHETER: UNKNOWN, ASSIST STENT: ATLAS 3X21/STRYKER Y CONNECTOR: UNKNOWN. USED COILS: KENEKA COILS (QTY. 6), TERUMO COILS (QTY. 5), JAPAN LIFELINE COILS (QTY. 4), OPTIMA COILS (QTY. 4), MEDTRONIC COILS (QTY. 2), AND STRYKER COIL (QTY. 1). DETAILED DESCRIPTION: FOR THE ANEURYSM AT THE C2 PORTION OF THE IC, THE PHYSICIAN PERFORMED COIL EMBOLIZATION USING A DOUBLE CATHETER TECHNIQUE. THE REPORTED OPTIMA COIL WAS USED AS THE SECOND COIL. INITIALLY, AN AXIUM PRIME 10×40 COIL WAS DEPLOYED AS A FRAMING COIL WITH A PHENOM 17 MICROCATHETER, WITHOUT DETACHMENT. SUBSEQUENTLY, THE REPORTED OPTIMA COIL WAS DEPLOYED FROM A GREACH MICROCATHETER. WHILE REPOSITIONING THE OPTIMA IMPLANT COIL WITHIN THE ANEURYSM TO ACHIEVE THE DESIRED SHAPE, THE PHYSICIAN FOUND THAT THE COIL HAD STRETCHED. THEREFORE, THE PHYSICIAN DETACHED THE FIRST AXIUM PRIME 10×40 COIL, INSERTED A GUIDEWIRE, AND REPLACED THE PHENOM 17 MICROCATHETER WITH AN EXCELSIOR 1018. USING A ONE SNARE, THE STRETCHED PORTION OF THE OPTIMA COIL WAS RETRIEVED. THE GREACH MICROCATHETER WAS THEN CONTINUED TO BE USED WITHOUT REPLACEMENT, AND THE PROCEDURE WAS CONTINUED WITH COMPETITIVE COILS OF THE SAME SIZE. A TOTAL OF 21 COILS WERE USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PROCEDURE DID NOT INVOLVE THE TORTUOUS ANATOMY. THE FIRST AXIUM PRIME 10×40 COIL AND THE AVENIR COIL DEPLOYED WITHIN THE ANEURYSM WITHOUT ANY PROBLEMS. DURING THE PRE-CHECK OF THE REPORTED OPTIMA COIL, NO PROBLEMS WERE FOUND." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727413 OPTIMA COIL SYSTEM OPTIMA HCG BALT USA OPTI0930CSFMX F231001048 00818053025266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention