BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2853691 · Received December 3, 2012

    Report

    Report Number
    1058196-2012-00430
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    WHILE ADVANCING THE 2X2 ORBIT MINI COMPLEX FILL COIL (637MF0202/15525135) WHEN PART OF THE COIL WAS IN THE ANEURYSM, IT WAS NOTED THAT THE PROXIMAL END OF THE COIL WAS "VAGUE" UNDER FLUOROSCOPY; IT WAS SUSPECTED THAT THE COIL WAS STRETCHED. BECAUSE PART OF THE COIL WAS ALREADY IMPLANTED IN THE ANEURYSM, IT COULD ONLY BE CONTINUED TO BE ADVANCED SLOWLY. THE COIL WAS SUCCESSFULLY IMPLANTED WITHOUT ANY PATIENT INJURY. THE PROCEDURE WAS TREATMENT OF A 2.6X2.5MM POSTERIOR COMMUNICATING (PCOM) ANEURYSM. THE COIL WAS NOT BEING REPOSITIONED WHEN IT STRETCHED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED. THERE IS NO INFORMATION REGARDING THE MICROCATHETER USED TO DELIVER THE COIL. A NON-STERILE 2X2 ORBIT MINI COMPLEX FILL DELIVERY SYSTEM WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS RETURNED UNZIPPED AND IN GOOD CONDITION. THE SUPPORT COIL AND GRIPPER WERE OUTSIDE OF THE INTRODUCER AND IN GOOD CONDITION. THE HEADPIECE WAS STILL ATTACHED TO THE GRIPPER; WHILE THE EMBOLIC COIL WAS SEPARATED FROM THE HEADPIECE AND WAS NOT RETURNED FOR ANALYSIS. AS REPORTED, THE COIL REMAINS IMPLANTED. SOME WAVES WERE FOUND ON THE PRODUCT BUT IT APPEARS THAT THIS MAY HAVE OCCURRED DURING THE HANDLING OF THE UNIT WHEN IT WAS RETURNED FOR EVALUATION. THE GRIPPER AND HEADPIECE WERE INSPECTED UNDER MICROSCOPE; THEY WERE CONFIRMED TO BE IN GOOD CONDITION. THE HEADPIECE WAS STILL ATTACHED TO THE GRIPPER, AND THE SOLDERED SECTION BETWEEN HEADPIECE AND THE COIL LOOPS WAS NOT FRACTURED INDICATING THAT THE SOLDER HAD A GOOD ADHESION TO THE HEADPIECE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED UNRAVELING OF THE COIL COULD NOT BE EVALUATED SINCE AS REPORTED IT WAS IMPLANTED. HOWEVER, BASED ON THE FINDING OF COIL SEPARATION FROM THE HEAD PIECE WITH EVIDENCE OF GOOD ADHESION OF THE SOLDER, IT APPEARS THAT THE DEVICE WAS SUBJECTED TO PULL FORCES BEYOND TOLERANCES. WITH REVIEW OF THE AVAILABLE INFORMATION AND THE ANALYSIS, THE EXACT CAUSE OF THE REPORTED STRETCHING OF THE COIL AND OBSERVED KINKS ON THE HYPOTUBE AND SEPARATION OF THE COIL FROM THE HEADPIECE CANNOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORDS REVIEW AND ANALYSIS DO NOT INDICATE THAT THERE ARE ANY MANUFACTURING ISSUES RELATED TO THE EVENT OR THE CONDITION OF THE RETURNED DEVICE. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF DAMAGES FROM LEAVING THE FACILITY. PROCEDURAL FACTORS INCLUDING VESSEL CHARACTERISTICS, INTERACTION WITH THE UNKNOWN MICROCATHETER, DEVICE MANIPULATION MAY HAVE IMPACTED THE EVENT; HOWEVER, NO CONCLUSION CAN BE MADE. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. EVALUATION SUMMARY ATTACHED.

    Description of Event or Problem · 1

    AS REPORTED, THE PATIENT CAME IN FOR TREATMENT OF PCOM ANEURYSM. THE ANEURYSM WAS 2.6 X2.5MM. DURING THE ADVANCEMENT PROCESS, THE PHYSICIAN FOUND THE PROXIMAL SIDE UNDER FLUOROSCOPY WAS VAGUE, HE COULD NOT WITHDRAW. SINCE PART OF THE COIL WAS ALREADY IMPLANTED INTO THE ANEURYSM, THE PHYSICIAN COULD ONLY CONTINUE TO SLOWLY ADVANCE. IT WAS SUSPECTED THAT THE COIL WAS STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15525135

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MICROCATHETER