BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851709 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02326
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    November 12, 2009
    Report Date
    November 12, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THERE WERE BENT AND BROKEN VESSEL LOCATOR WINGS. IT WAS DETERMINED THAT ALL OF THE BROKEN WING MATERIAL WAS RETURNED WITH THE DEVICE AND ALL WING ATTACHMENTS POINTS WITHIN THE VESSEL LOCATOR WERE STILL SECURE. THE THUMB ADVANCER AND CLIP DELIVERY TUBE SET WERE STILL FULLY DISTALLY DEPLOYED AND LOCKED IN POSITION. IT COULD NOT BE CONFIRMED THAT THE ACCESS PORTS HAD BEEN ACTIVATED. THE BENT AND BROKEN VESSEL LOCATOR WINGS COULD HAVE BEEN CAUSED BY PROCEDURAL OR ANATOMICAL CONDITIONS. PROCEDURALLY, DISTAL PRESSURE CAN BE APPLIED TO THE DEPLOYED LOCATOR WINGS DURING THE DEPLOYMENT OF THE CLIP DELIVERY TUBE SET THROUGH THE TISSUE TRACT. THIS CAN COMPACT TISSUE BETWEEN THE LOCATOR WINGS AND THE DISTAL END OF THE CLIP DELIVERY TUBE, PUSHING THE DEPLOYED LOCATOR WINGS DISTALLY AWAY FROM THE OPERATOR. THIS CONDITION CAN INHIBIT CORRECT LOCATOR WING RETRACTION INTO THE DISTAL END OF THE DELIVERY TUBE AFTER CLIP DEPLOYMENT, DAMAGING THE WINGS. ANATOMICALLY, ANY FEATURE WITHIN THE BODY, SCAR TISSUE, CALCIFICATION ETC. THAT MAY PREVENT CORRECT LOCATOR WING RETRACTION MAY HAVE BEEN ENCOUNTERED. HOWEVER, NO ANATOMICAL INFORMATION WAS SUPPLIED. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE REPORTED EVENT IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. 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 TRAINED IN THE USE OF THE STARCLOSE SE ATTEMPTED ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED TO REMOVE THE DEVICE FROM THE PATIENT'S ANATOMY. ONCE REMOVED, IT WAS NOTICED THAT THE LOCATOR WINGS WERE STILL IN THE OPEN POSITION. HEMOSTASIS WAS ACHIEVED WITH THE STARCLOSE SE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, 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 80003-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention