BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 6725772 · Received July 19, 2017

    Report

    Report Number
    3013394970-2017-00159
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    May 29, 2017
    Report Date
    July 19, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 6F ANGIOSEAL STS PLUS WAS RETURNED FOR EVALUATION. THE CARRIER TUBE ASSEMBLY WAS MATED WITH THE HEMOSTASIS SHEATH AND THE DEPLOYMENT SLEEVES WERE IN THE FULL REAR LOCK POSITION. THERE WAS NO RELEASE OF SUTURE AND THE ANCHOR AND COLLAGEN FORMED THE KNOT AT THE TIP OF THE HEMOSTASIS SHEATH. THERE WAS BLOOD LIKE SUBSTANCE OBSERVED ON ALL RETURNED COMPONENTS. THE CARRIER TUBE HUB CAP WAS DISASSEMBLED TO CHECK SUTURE POSITION WITHIN THE WINDING DISC. ALL TURNS OF SUTURE WERE LEFT WITHIN THE SPOOL. THERE WAS EXCESSIVE BLOOD LIKE SUBSTANCE NOTED ON THE TENSIONER HUB WHICH MAY HAVE POSSIBLY CAUSED THE SUTURE MECHANISM TO MALFUNCTION. UPON DISASSEMBLING THE CARRIER TUBE FROM THE HEMOSTASIS SHEATH, SIGNIFICANT AND EXCESSIVE ACCUMULATION OF BLOOD LIKE SUBSTANCE WAS NOTED. THE TAMPER TUBE OUTER DIAMETER WAS MEASURED, THE CARRIER TUBE OUTER DIAMETER WAS MEASURED, AND THE INNER DIAMETER WAS MEASURED AND CONFIRMED TO MANUFACTURER SPECIFICATION. THE INNER DIAMETER OF THE HEMOSTASIS SHEATH WAS MEASURED AND CONFIRMED TO MEET MANUFACTURER SPECIFICATION. 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. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH TERUMO MEDICAL CORPORATION SPECIFICATIONS AND PROCEDURES. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION IT IS LIKELY THAT ACCUMULATION OF EXCESSIVE BLOOD LIKE SUBSTANCE LED TO SEIZING OF THE MECHANISM LEADING TO FAILURE OF THE DEVICE TO RELEASE SUTURE AS INTENDED. 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 A WITHDRAWAL FAILURE ON THE ANGIO-SEAL DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: AFTER FIRST CLICK, SECOND CLICK WAS HEARD, BUT WHEN TRIED TO REMOVE BACK THE SYSTEM THERE WAS A SIGNIFICANT REACTION AND THE SYSTEM WAS STUCK IN THE VESSEL. THEY DIDN'T WANT TO FORCE ANYMORE, AND VASCULAR SURGEONS PERFORMED SURGERY TO THE PATIENT TO REMOVE THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON 6/28/2017: IT WAS AN ANEURYSM TREATMENT. AFTER THE TREATMENT, THE PHYSICIAN HAD WANTED TO CLOSE THE VESSEL WITH ANGIO-SEAL. BUT THE ANGIO-SEAL WAS STUCK IN THE VESSEL, SO THEY HAVE DECIDED TO CALL CARDIOVASCULAR SURGEONS. THEY HAVE CUT THE FEMORAL REGION TO REACH FEMORAL ARTERY AND STUCK ANGIO-SEAL. THE BLOOD LOSS WAS GREATER THAN 250 CC, BUT NOT TOO MUCH TO AFFECT THE PATIENT'S CONDITION. THE PATIENT IS WELL NOW. HE WAS DISCHARGED AFTER THE PROCEDURE. THE PATIENT WAS DISCHARGED FIVE DAYS LATER AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506278 6F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 5842127

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention