BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851814 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02262
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 9, 2010
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE LOCATOR WINGS WERE INITIALLY BENT DURING THUMB ADVANCER DEPLOYMENT DUE TO TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS, PREVENTING THE WINGS FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS FIRED. THE FAILURE OF THE WINGS TO COMPLETELY COLLAPSE INTO THE DELIVERY TUBESET DIRECTLY RESULTED IN DIFFICULT DEVICE REMOVAL. THE DEVICE WAS SUCCESSFULLY REMOVED VIA UTILIZING THE ACCESS PORTS BUT, ALL OF THE WINGS WERE DETACHED FROM THE DISTAL RETAINING RING DUE TO COUNTER-TRACTION AND ASSERTIVE PULL. ALL BROKEN WINGS REMAINED SECURE WITHIN THE LOCATOR. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE DAMAGED LOCATOR WINGS (BENT AND BROKEN) 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 MANUFACTURING 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 ACHIEVED ARTERIOTOMY CLOSURE IN THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE CLIP, THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, A DILATOR WAS INSERTED INTO THE ACCESS PORTS; HOWEVER, THE PHYSICIAN FAILED TO PULL BACK THE THUMB ADVANCER. THE DEVICE WAS REMOVED USING COUNTER-TRACTION AND ASSERTIVE PULL. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 85012-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention