BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851680 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02299
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 13, 2009
    Report Date
    August 13, 2009
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND THE LOCATOR WINGS WERE INITIALLY BENT DURING THUMB ADVANCER DEPLOYMENT, PREVENTING THE WINGS FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS FIRED. THE BENT LOCATOR WINGS DIRECTLY RESULTED IN DIFFICULT DEVICE REMOVAL. THE ACCESS PORTS WERE SUCCESSFULLY UTILIZED TO RELEASE THE LOCKING MECHANISM ON THE THUMB ADVANCER. ALTHOUGH THE DEVICE WAS SUCCESSFULLY REMOVED BY USING COUNTER-TRACTION AND ASSERTIVE PULL, FORCEFUL REMOVAL DIRECTLY RESULTED IN THE WINGS BEING BROKEN OFF THE DISTAL RETAINING RING. ALL WINGS REMAINED SECURE WITHIN THE LOCATOR. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS THAT DIRECTLY RESULTED IN THE REPORTED DIFFICULT DEVICE REMOVAL IS TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS WHILE IN THE TISSUE TRACT. TISSUE TRAPPED BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS CAN BEND THE WINGS AND EVENTUALLY BREAK THEM DURING FORCEFUL REMOVAL. NO MFG OR QUALITY ISSUES WERE DETECTED. 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 IN A VESSEL GRAFT OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PT'S ARTERY. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AN ATTEMPT WAS MADE TO USE THE ACCESS PORTS, HOWEVER, IT WAS UNSUCCESSFUL. THE DEVICE WAS ULTIMATELY REMOVED USING COUNTER-TRACTION AND ASSERTIVE PULL. HEMOSTASIS WAS ACHIEVED WITH THE CLIP AND LESS THAN 5 MINUTES OF MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 79017-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention