BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6841582 · Received September 5, 2017

    Report

    Report Number
    3013394970-2017-00339
    Event Type
    Injury
    Date Received
    September 5, 2017
    Date of Event
    August 4, 2017
    Report Date
    September 5, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION. ONE USED 6FR ANGIOSEAL STS PLUS DEVICE WAS RECEIVED FOR PRODUCT ANALYSIS AT TERUMO MEDICAL CORPORATION. THE DEVICE WAS RETURNED WITH THE GUIDEWIRE, AND ARTERIOTOMY LOCATOR. THE RETURNED COMPONENTS WERE SUBJECTED TO VISUAL ANALYSIS WHERE A BLOOD LIKE SUBSTANCE WAS FOUND ON ALL RETURNED DEVICES. THE HEMOSTATIC SHEATH WAS MATED WITH THE CARRIER TUBE ASSEMBLY WITH THE DEVICE CAP IN THE FULL REAR LOCK POSITION AND COLOR BANDS FULLY EXPOSED. THERE WAS NO ANCHOR EXPOSED AT THE DISTAL END OF THE HEMOSTATIC SHEATH. MICROSCOPIC ANALYSIS WAS THEN EMPLOYED TO DETERMINE IF THE ANCHOR WAS PRESENT WITHIN THE HEMOSTATIC SHEATH. A PORTION OF THE ANCHOR COULD BE SEEN. UPON THIS REALIZATION, THE DEVICE CAP WAS MOVED INTO THE FULL FORWARD LOCK POSITION. THE ANCHOR DID NOT POST AFTER THIS TRANSITION AS WOULD BE EXPECTED. THE DEVICE CAP WAS THEN MOVED TO THE PARTIAL REAR LOCK POSITION AND DISTAL TO THE DEVICE CAP A PORTION OF THE CARRIER TUBE ASSEMBLY COULD BE SEEN DEFORMED IN AN ACCORDION SHAPE AS THOUGH THE CARRIER TUBE ASSEMBLY HAD BUCKLED OR BECOME KINKED UNDER THE STRESS OF DEPLOYING THE ANCHOR. NO OBSTRUCTIONS OTHER THAN BLOOD LIKE SUBSTANCE WERE VIEWED IN THE INNER LUMEN OF THE HEMOSTATIC SHEATH. THE COMPLAINT COULD BE CONFIRMED FOR DEPLOYMENT DIFFICULTIES DUE TO THE KINK OBSERVED, AS THE ANCHOR DID NOT PROPERLY POST PROPERLY WHEN THE DEVICE CAP WAS IN THE FULL FORWARD LOCK POSITION. LIKELY, THERE WAS RESISTANCE BETWEEN THE HEMOSTATIC SHEATH AND ANCHOR THAT REQUIRED MORE DEPLOYMENT FORCE THAN THE CARRIER TUBE ASSEMBLY COULD SUPPORT. POSSIBLE CAUSES OF THIS IMBALANCE COULD BE DUE TO KINKING OR MISHANDLING OF THE CARRIER TUBE ASSEMBLY AS IT WAS INSERTED INTO THE HEMOSTATIC SHEATH, THE ADDED FRICTION IN THE HEMOSTATIC SHEATH FROM THE PRESENCE OF BLOOD LIKE SUBSTANCE, OR DIMENSIONAL MISALIGNMENT. 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.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS 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, (B)(4) HAS BEEN REFERENCED IN THE CONCLUSIONS SECTION OF EVALUATION CODES. 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.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DEPLOYMENT DIFFICULTIES WHEN USING THE ANGIOSEAL DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: AFTER THE PLACEMENT OF THE ANCHOR, IT WAS NOT POSSIBLE TO RELEASE THE COLLAGEN. THE PUNCTURE WAS NOT CLOSED AND WAS STILL BLEEDING. THE PHYSICIAN THEN REMOVED THE WHOLE ANGIOSEAL SYSTEM. DURING INSPECTION OF THE ANGIO-SEAL, THE PHYSICIAN REPORTED THAT THERE WAS NO COLLAGEN INSIDE. THE PUNCTURE SIGHT WAS COMPRESSED MANUALLY. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. IT WAS REPORTED THAT THE PATIENT STATUS WAS STABLE. IT WAS REPORTED THAT NO SECONDARY DAMAGES ARE KNOWN. STANDARD TR BAND WAS USED WITH THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 9, 2017. THERE WAS NO BLOOD LOSS. IT WAS REPORTED THAT THE PUNCTURE WAS IN THE SUBCUTANEOUS AREA AND THE DEVICE COULD BE EASILY REMOVED. IT WAS REPORTED THAT IN THIS CASE OF PUNCTURE THE WIRE WAS BROKEN AND AFTER SURGERY ALL PARTS WERE REMOVED. COMPRESSION WAS PERFORMED WITH A STANDARD TR BAND AND WAS CHECKED WITH X RAY. THE PATIENT'S HOSPITALIZATION STAY WAS FOUR DAYS LONGER. THE WIRE WAS REMOVED FRIDAY, (B)(6) 2017. THE PATIENT LEFT THE HOSPITAL (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT'S HOSPITALIZATION WAS NOT EXTENDED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622591 6F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 5929762

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention