BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 6676304 · Received June 29, 2017

    Report

    Report Number
    3013394970-2017-00126
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    May 31, 2017
    Report Date
    June 29, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    05414734020527
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. ONE 6F ANGIOSEAL VIP WAS RETURNED FOR PRODUCT EVALUATION TO TERUMO MEDICAL CORPORATION IN (B)(4). THE CARRIER TUBE ASSEMBLY WAS RETURNED MATED WITH THE HEMOSTASIS SHEATH. THE DEVICE SHEATH WAS BENT IN A SHALLOW CURVE. THE HUB OF THE CARRIER TUBE ASSEMBLY WAS NOT LOCKED COMPLETELY INTO THE HEMOSTASIS SHEATH HUB BUT THE DEPLOYMENT SLEEVE WAS POSITIONED IN A CANTED ORIENTATION. THE GREEN TAMPER TUBE EXITED FROM THE END OF HEMOSTASIS SHEATH TUBE AND WAS CURVED AS WELL. BLOOD LIKE SUBSTANCE WAS OBSERVED ON ALL RETURNED COMPONENTS. THE CANTED ORIENTATION OF THE RETURNED DEPLOYMENT SLEEVE SUGGESTS THAT THE CARRIER TUBE ASSEMBLY WAS NOT COMPLETELY LOCKED ONTO THE HEMOSTASIS SHEATH HUB DURING FORWARD LOCK POSITION. SUBSEQUENTLY, WHEN THE DEVICE WAS ATTEMPTED TO BE PULLED TO THE REAR LOCK POSITION WITH OFF AXIS FORCE, THE INSUFFICIENT CONNECTION BETWEEN THE DEPLOYMENT SLEEVE AND THE HUB LED TO CANTED ORIENTATION AS SEEN. THE DEVICE WAS ABLE TO BE FUNCTIONALLY CHECKED BY REPOSITIONING THE DEPLOYMENT SLEEVE AND THE LOCKING MECHANISM FUNCTIONED AS INTENDED. THE COMPLAINT IS CONFIRMED FOR THE FAILURE MODE OF USER ERROR. VISUAL AND FUNCTIONAL INSPECTION LED TO THE CONCLUSION THAT NO ANOMALIES WERE FOUND INTRINSIC TO THE DEVICE THAT COULD HAVE LED TO THIS EVENT. THE DEPLOYMENT SLEEVE WORKED AS INTENDED UPON FUNCTIONAL CHECK. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH TERUMO MEDICAL CORPORATION SPECIFICATIONS AND PROCEDURES. 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 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. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. 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

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE THE EVALUATION CODES. THE CODES WERE UNABLE TO BE SELECTED WHEN FOLLOW UP NO. 1 REPORT WAS SUBMITTED, THE CODES ARE NOW AVAILABLE AND HAVE BEEN SELECTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE SUTURE CAME OUT OF THE ANGIO-SEAL DEVICE. THE FOLLOWING INFORMATION WAS REPORTED: AT THE END OF THE ANGIOGRAM, THE DOCTOR DEPLOYED THE 6 FRENCH ANGIOSEAL VIP; THE DOCTOR REPORTED THAT THE DEVICE DEPLOYED WAS FAULTY BECAUSE AFTER THE ANGIOSEAL WAS DEPLOYED, HE TRIED TO PULL BACK AND THE DEVICE SNAPPED; THE DOCTOR CHECKED IF COLLAGEN FROM ANGIOSEAL ENTERED THE PATIENT'S ARTERY AND IT DID NOT; PATIENT WAS SENT TO THE WARD AFTER PROCEDURE AS PER USUAL POST-ANGIOGRAPHY; AND NO INJURY TO THE PATIENT WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 6/1/17. ACCORDING TO THE DOCTOR, THERE WAS NO MECHANISM ACTIVATED ON ANGIOSEAL'S BUTTON (BUTTON DID NOT SPRING BACK) AND THAT WHEN HE MENTIONED THE WORD "SNAP", HE MEANS TO SAY THE DEVICE BROKE WHEN HE TRIED TO PULL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457017 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS HEMOSTASIS VASCULAR DEVICE MGB TERUMO MEDICAL CORPORATION NA 5763288 05414734020527

    Patients

    Seq Age Sex Outcome Treatment
    1