BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 6628076 · Received June 8, 2017

    Report

    Report Number
    2024168-2017-04915
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    May 19, 2017
    Report Date
    August 3, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED INCOMPLETE SHEATH SPLIT WAS NOT CONFIRMED AS THE DEVICE WAS RETURNED WITH THE SHEATH SPLIT COMPLETED AND CLIP DEPLOYED. AS THE DEVICE WAS REPORTEDLY MANIPULATED POST PROCEDURE, A CONCLUSIVE CAUSE COULD NOT BE DETERMINE FOR THE REPORTED DIFFICULTY. THE TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. ATTACHMENT: USER FCILITY SUS VOLUNTARY EVENT REPORT (MW5069985). MEDWATCH: MW5069985 REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE WITH A 6F SHEATH AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE STARCLOSE SE SHEATH WOULD NOT SPLIT. THE SAFETY RELEASE MECHANISM WAS USED TO REMOVE THE STARCLOSE SE DEVICE. HEMOSTASIS WAS ACHIEVED BY APPLYING MANUAL ARTERIAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    RECEIVED USER FACILITY SUS VOLUNTARY EVENT REPORT (MW5069985) STATING: VASCULAR CLOSURE DEVICE MALFUNCTIONED. ATTENDING MD REMOVED RIGHT FEMORAL ARTERY SHEATH AND ABBOTT STARCLOSE SE LOT #7030241 FAILED TO DEPLOY AS INTENDED. MANUAL PRESSURE WAS HELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409473 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 7030241

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention