BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1031407 · Received April 18, 2008

    Report

    Report Number
    1058196-2008-00101
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 15, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF THE PLASTIC BAG. KINKS/BEND WERE FOUND ON THE HYPOTUBE. THE INTRODUCER WAS KINKED AND THIS WAS RECEIVED ZIPPED. THE EMBOLIC COIL WAS RECEIVED ATTACHED TO THE GRIPPER; HOWEVER, IT WAS OUT OF THE INTRODUCER. WITH MICROSCOPIC EXAMINATION OF THE COIL, IT WAS NOTED THAT THE COIL WAS STRETCHED. ADDITIONALLY, FIBERS WERE FOUND AROUND THE EMBOLIC COIL. THE FIBER WAS IDENTIFIED AS PET (POLYETHYLENE TEREPLITHALATE), AND THE ORIGIN OF IT COULD NOT BE DETERMINED, AS THIS MATERIAL IS NOT USED DURING THE MANUFACTURE PROCESS ON CORDIS. A DEVICE HISTORY REPORTS REVIEW WAS PERFORMED FOR THIS LOT AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MQP (MANUFACTURING QUALITY PLAN), INCLUDING FINAL ASSEMBLY INSPECTION PER TEST RESULT. IT WAS REPORTED THAT THE KINKED DELIVERY WIRE OCCURRED DURING REMOVAL FROM THE PACKAGING. BASED ON THIS INFO, IT APPEARS THAT HANDLING OF THE DEVICE CAUSED THE EVENT. BECAUSE THE CUSTOMER CONFIRMED THAT THE COIL WAS NOT STRETCHED PRIOR TO SHIPPING, IT CAN BE OCCLUDED THAT THE STRETCHING OF THE COIL OCCURRED DURING PROCESSING AND HANDLING OF THE DEVICE FOR RETURN. THE DEVICE WAS RECEIVED WITH THE COIL EXPOSED, AND THE CUSTOMER DID NOT NOTE THE MATERIAL FOUND ON THE RETURNED COIL. BASED ON THIS, THERE IS NO INDICATION THAT THESE ISSUES ARE RELATED TO THE MANUFACTURING PROCESS, BUT ARE RELATED TO PRODUCT HANDLING. INSPECTIONS ARE IN PLACE TO PREVENT COIL DAMAGES ON TRUFILL DCS ORBIT LEAVING THE FACILITY; THEREFORE, NO CORRECTIVE ACTION WAS TAKEN.

    Description of Event or Problem · 1

    THE BOX AND INNER PACKAGING WAS NOT DAMAGED. THE PRODUCT WAS STORED FLAT IN THE BOX. THE KINK OCCURRED AS THE PRODUCT WAS BEING REMOVED FROM THE PACKAGING. ANALYSIS OF THE RETURNED PRODUCT FOUND THE COIL WAS STRETCHED AND THERE WERE FIBERS AROUND THE EMBOLIC COIL. THE CUSTOMER VERIFIED THAT THE COIL WAS NOT STRETCHED PRIOR TO RETURNING, AND REPORTED IT HAD NOT BEEN WIPED DOWN WITH GAUZE PRIOR TO RETURNING FOR ANALYSIS. THERE IS NO RISK OF INJURY TO THE PT DUE TO THE KINKED DELIVERY WIRE AS REPORTED BY THE CUSTOMER. ALTHOUGH THE TYPE OF MATERIAL (FIBERS) FOUND ON THE RETURNED COIL ARE NOT USED DURING THE MANUFACTURING PROCESS OF THE TRUFILL DCS ORBIT COIL, SINCE THE ORIGIN OF THE MATERIAL CANNOT BE DETERMINED, BASED ON THE FINDINGS OF THE ANALYSIS, THIS HAS BEEN RE-DETERMINED TO BE REPORTABLE TO THE FDA.

    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 13255543

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK