BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US

    MDR report key: 6634073 · Received June 12, 2017

    Report

    Report Number
    3013394970-2017-00087
    Event Type
    Malfunction
    Date Received
    June 12, 2017
    Date of Event
    May 8, 2017
    Report Date
    June 12, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    05414734004992
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. FOR THIS REASON, EVALUATION CODE HAS BEEN REFERENCED IN THE CONCLUSIONS. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND ONE SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. DEVICE CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE EVALUATION RESULTS. ONE 6F ANGIOSEAL STS WAS RETURNED TO TERUMO MEDICAL CORPORATION IN (B)(4). ONE ARTERIOTOMY LOCATOR, ONE CARRIER TUBE ASSEMBLY AND ONE HEMOSTASIS SHEATH WAS RETURNED. THE ARTERIOTOMY LOCATOR WAS MATED WITH THE HEMOSTASIS SHEATH. BOTH BLOOD INLET HOLES WERE ALIGNED. A BLOOD-LIKE SUBSTANCE (BLS) WAS SEEN ON THE MATED ASSEMBLY. THE CARRIER TUBE ASSEMBLY APPEARED UNUSED WITH BYPASS TUBE SECURE AT ITS MANUFACTURING POSITION. THERE WAS NO APPARENT KINKING AND FOLDING NOTICED ON ANY OF THE RETURNED COMPONENTS. UPON VISUAL INSPECTION THERE WERE NO APPARENT ANOMALIES NOTED AND THE DEVICE. DURING FUNCTIONAL TESTING,THE LOCATOR WAS REMOVED FROM THE SHEATH AND CARRIER TUBE ASSEMBLY WAS ADVANCED OVER THE HEMOSTASIS SHEATH; THE DEVICE WAS PUSHED TO FULL FORWARD LOCK POSITION AND THE ANCHOR EXITED THE CARRIER TUBE. UPON PULLING THE ASSEMBLY HUB TO REAR LOCK POSITION THE ANCHOR POSTED AGAINST THE DISTAL END OF THE CARRIER TUBE AS INTENDED. THE ANCHOR WAS MANUALLY PULLED TO REVEAL COLLAGEN. THE ANCHOR WAS GRASPED AND THE SUTURE/COLLAGEN/BLACK HEAT SHRINK EXTRACTED; THE TAMPER TUBE WAS EXTRACTED AS WELL AND WAS MANUALLY ADVANCED TO MOVE OVER THE COLLAGEN TO FORM A SUCCESSFUL ANCHOR/COLLAGEN KNOT. THE DEVICE FUNCTIONED AS INTENDED. THE COMPLAINT CANNOT BE CONFIRMED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY INSPECTED AND PERFORMED AS INTENDED. THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED; THERE WE NO KINKS AND FOLDS OBSERVED ON THE RETURNED DEVICE AS ALLEGED. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE INCIDENT WAS DUE TO AN INTRINSIC DEFECT IN THE RETURNED DEVICE. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING TERUMO MEDICAL CORPORATION MANUFACTURING FACILITIES AS SUPPORTED BY THE DEVICE HISTORY THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE THE COMPLETED INVESTIGATION. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DIFFICULTIES WITH THE ANGIO-SEAL DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE PHYSICIAN WENT TO INTRODUCE THE ANGIO-SEAL OVER THE WIRE IN THE RIGHT FEMORAL ARTERY, WHEN TURNING THE ANGIO-SEAL SHAFT DURING INSERTION, THE SHAFT GOT COMPRESSED; THEY STOPPED USING THE ANGIO-SEAL DEVICE AND USED A NEW ONE; THE NEW ANGIO-SEAL WAS INTRODUCED WITHOUT ANY PROBLEMS AND THERE WAS NO FURTHER COMPLICATIONS; THE PATIENT WAS TREATED AS INTENDED AND SUFFERED NO CONSEQUENCES; IT WAS REPORTED THAT THE PATIENT WAS STABLE AND WAS DISCHARGED FROM THE HOSPITAL AS PLANNED; AND THERE WAS NO REPORTED BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414712 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION NA 5850895 05414734004992

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR