BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 6591456 · Received May 25, 2017

    Report

    Report Number
    3013394970-2017-00070
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Date of Event
    May 3, 2017
    Report Date
    May 25, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    05414734005012
    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 WAS NOT RETURNED TO THE MANUFACTURER FACILITY FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. 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 DID NOT FIND ANY OTHER 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE THE COMPLETED INVESTIGATION. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED ON THE USER FACILITY INFORMATION AND THE DEVICE HISTORY RECORDS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED. BASED ON HISTORICAL SEARCH OF THE COMPLAINTS DATABASE, THE USER ALLEGATIONS OF TIP FRAYED/DAMAGE OF THE DISTAL CARRIER TUBE TIP EITHER REFER TO THE CARRIER TUBE SLIT/SLOT OR THE TIP MONOFOLD WHICH ARE BOTH MANUFACTURING FEATURES. BASED ON THIS LIMITED INVESTIGATION THERE IS NO EVIDENCE FOUND TO SUGGEST THAT THE INCIDENT WAS DUE TO AN INTRINSIC DEFECT IN THE DEVICE. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING TERUMO MEDICAL CORPORATION MANUFACTURING FACILITIES AS SUPPORTED BY THE DEVICE HISTORY RECORD. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN. 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 THAT THE TIP OF THE INVOLVED ANGIO-SEAL STS DEVICE IS FRAYED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: (1) DURING THE PREPARATION THE PHYSICIAN SAW THAT THE TIP WAS HAD A DEFECT; (2) THE ANGIO-SEAL DID NOT HAVE ANY CONTACT TO THE PATIENT; AND (3) THE PATIENT CONDITION IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373246 8F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION NA 5536456 05414734005012

    Patients

    Seq Age Sex Outcome Treatment
    1