BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2499193 · Received March 21, 2012

    Report

    Report Number
    1058196-2012-00130
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    March 9, 2012
    Report Date
    March 12, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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

    A NON-STERILE ORBIT RDFL COMPLEX FILL COIL WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND KINKED. THE INTRODUCER WAS RECEIVED UNZIPPED WITHOUT DAMAGE JUST RESIDUES OF DRY BLOOD CAN BE OBSERVED INSIDE OF IT. THE SUPPORT COIL WAS RECEIVED OUTSIDE OF THE INTRODUCER WITHOUT DAMAGE. THE GRIPPER WAS RECEIVED STUCK WITH THE INTRODUCER AND THE EMBOLIC OIL WAS RECEIVED INSIDE OF THE INTRODUCER WITH STRETCHED CONDITION AND RESIDUES OF DRY BLOOD CAN BE OBSERVED ON IT. THE GRIPPER AND EMBOLIC OIL WERE INSPECTED UNDER MICROSCOPE. THE GRIPPER WAS RECEIVED STUCK WITH THE INTRODUCER AND THE EMBOLIC OIL WAS RECEIVED INSIDE OF THE INTRODUCER WITH STRETCHED CONDITION AND RESIDUES OF DRY BLOOD CAN BE OBSERVED ON IT. 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 FAILURE REPORTED BY THE COSTUMER AS "COIL - UNRAVELED/STRETCHED" WAS CONFIRMED. THE DAMAGE FOUND ON THE DEVICE AND THE FAILURE EXPERIENCED BY THE COSTUMER COULD NOT BE CONCLUSIVELY DETERMINATE; NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD NOT BE RELATED TO THE MANUFACTURING PROCESS AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THESE DAMAGES. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF FAILURES LEAVING FROM THE FACILITY. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING REPOSITIONING IN THE ANEURYSM, THE ORBIT RDFL COMPLEX FILL COIL ((B)(4)) STRETCHED. THE PHYSICIAN CHANGED COIL AND THE PROCEDURE WAS SUCCESSFULLY DONE. DURING REPOSITIONING, THE COIL WAS NOT LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. AFTER THE EVENT, THE COIL AND DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUES, AND AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. NO DAMAGES WERE NOTICED AFTER IT WAS RESHAPED. NO RESISTANCE WAS NOTED WHEN THE COIL WAS INSERTED IN THE MICROCATHETER OR ANY OTHER TIME, AND THERE WERE NO KINKS IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. A NON-STERILE ORBIT RDFL COMPLEX FILL COIL WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND KINKED. THE INTRODUCER WAS RECEIVED UNZIPPED WITHOUT DAMAGE JUST RESIDUES OF DRY BLOOD CAN BE OBSERVED INSIDE OF IT. THE SUPPORT COIL WAS RECEIVED OUTSIDE OF THE INTRODUCER WITHOUT DAMAGE. THE GRIPPER WAS RECEIVED STUCK WITH THE INTRODUCER AND THE EMBOLIC OIL WAS RECEIVED INSIDE OF THE INTRODUCER WITH STRETCHED CONDITION AND RESIDUES OF DRY BLOOD CAN BE OBSERVED ON IT. THE GRIPPER AND EMBOLIC OIL WERE INSPECTED UNDER MICROSCOPE. THE GRIPPER WAS RECEIVED STUCK WITH THE INTRODUCER AND THE EMBOLIC OIL WAS RECEIVED INSIDE OF THE INTRODUCER WITH STRETCHED CONDITION AND RESIDUES OF DRY BLOOD CAN BE OBSERVED ON IT. 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 STRETCHED COIL WAS CONFIRMED. THE CAUSE OF THE DAMAGE FOUND ON THE DEVICE AND THE EVENT EXPERIENCED BY THE COSTUMER COULD NOT BE CONCLUSIVELY DETERMINED; NEITHER THE ANALYSIS NOR THE DEVICE HISTORY RECORDS INDICATE A RELATIONSHIP TO THE MANUFACTURING PROCESS. IT IS POSSIBLE THAT PROCEDURAL FACTORS CONTRIBUTED; HOWEVER, NO CONCLUSION CAN BE MADE. INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURE FROM LEAVING THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING REPOSITIONING IN THE ANEURYSM, THE ORBIT RDFL COMPLEX FILL COIL (B)(4) STRETCHED. THE PHYSICIAN CHANGED COIL AND THE PROCEDURE WAS SUCCESSFULLY DONE. DURING REPOSITIONING, THE COIL WAS NOT LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. AFTER THE EVENT, THE COIL AND DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUES, AND AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. NO DAMAGES WERE NOTICED AFTER IT WAS RESHAPED. NO RESISTANCE WAS NOTED WHEN THE COIL WAS INSERTED IN THE MICROCATHETER OR ANY OTHER TIME, AND THERE WERE NO KINKS IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION OR ANY OTHER TIME, NO RESISTANCE WAS MET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15358306

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER