BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1981806 · Received February 8, 2011

    Report

    Report Number
    2024168-2011-00757
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    October 10, 2010
    Report Date
    January 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE INDICATED IT WAS RETURNED FULLY CLIP-DEPLOYED. THE LOCATOR WINGS WERE FOUND BENT, WHICH LIKELY PREVENTED THEM FROM FULLY COLLAPSING INTO THE CLIP DELIVERY TUBESET DURING CLIP DEPLOYMENT. BECAUSE THE LOCATOR WINGS DID NOT COMPLETELY COLLAPSE INTO THE CLIP DELIVERY TUBESET, THIS DIRECTLY RESULTED IN THE DIFFICULTLY ENCOUNTERED REMOVING THE DEVICE. THE DEVICE WAS SUCCESSFULLY REMOVED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) BY UTILIZING THE ACCESS PORTS TO RELEASE THE LOCKING MECHANISM ON THE THUMB ADVANCER. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS THAT DIRECTLY RESULTED IN THE REPORTED DIFFICULTY ENCOUNTERED REMOVING THE DEVICE IS TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE LOCATOR WINGS WHILE IN THE TISSUE TRACT. SUBCUTANEOUS TISSUE TRAPPED BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS CAN BEND THE LOCATOR WINGS AND INTERFERE WITH CLIP DEPLOYMENT. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, A DILATOR WAS INSERTED INTO THE ACCESS PORTS UNLOCKING THE THUMB ADVANCER AND CLIP DELIVERY TUBESET ENABLING THEM TO BE RETRACTED PROXIMALLY, WHICH RELEASED THE DEVICE FROM THE TISSUE TRACT. WHEN THE DEVICE WAS REMOVED, BLEEDING CONTINUED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 920426H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention