BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1842241 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01940
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    August 28, 2009
    Report Date
    August 28, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED WITH THE THUMB ADVANCER AND THE TUBE SET RETRACTED. THE SAFETY RELEASE WAS PROXIMAL AND MOVED FREELY. THESE FINDINGS ARE CONSISTENT WITH THE REPORTED PRODUCT EXPERIENCE AND USE OF THE SAFETY RELEASE FUNCTION. THE EXTERNAL AND INTERNAL COMPONENTS WERE IN THE CORRECT RETRACTED POSITIONS WITH THE EXCEPTION OF THE LOCATOR WINGS. THE LOCATOR WINGS WERE BROKEN AT THE DISTAL RETAINING RING, BUT REMAINED ATTACHED TO THE DEVICE AT THE PROXIMAL RETAINING RING AND PUSHER BODY BONDS. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE REPORTED EXCESSIVE FORCE USED TO REMOVE THE DEVICE FORM THE PT'S ANATOMY. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE ROOT CAUSE FOR THE BROKEN LOCATOR WINGS AND SUBSEQUENT DIFFICULT REMOVAL WAS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MANUFACTURING OR QUALITY ISSUES WERE 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 ACHIEVED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER FIRING THE CLIP, THE DEVICE COULD NOT BE REMOVED FROM THE PT ANATOMY. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AN ATTEMPT WAS MADE TO USE THE ACCESS PORTS, HOWEVER, IT WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED USING COUNTER-TRACTION AND ONE FIRM PULL. HEMOSTASIS WAS ACHIEVED AFTER 4 MINUTES OF MANUAL COMPRESSION. THERE WAS NO ADVERSE PT SEQUELAE REPORTED. THOUGH REQUESTED, 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 79013-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 6F INTRODUCER SHEATH