BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851809 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02270
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    March 23, 2010
    Report Date
    March 31, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED AND IN THE ACCESS PORT RETRACTED STATE WITH BROKEN VESSEL LOCATOR WINGS. THE DEPLOYED CLIP WAS NOT RETURNED. INSPECTION OF THE VESSEL LOCATOR CONFIRMED THE PUSHER BODY JOINT TO BE INTACT AND ALL OF THE BROKEN WING MATERIAL RETURNED WITH SECURE ATTACHMENT POINTS FOR THE VESSEL LOCATOR WINGS. NO OTHER DAMAGE WAS DETECTED. BASED ON THE INVESTIGATION FINDINGS, A POSSIBLE CAUSE FOR THE DAMAGED WING CONDITION WAS RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE, EITHER PROCEDURAL OR ANATOMICAL. PROCEDURALLY, DISTAL PRESSURE CAN BE APPLIED TO THE DEPLOYED LOCATOR WINGS DURING THE DEPLOYMENT OF THE CLIP DELIVERY TUBE SET THROUGH A TIGHT TISSUE TRACT, POSSIBLY FROM AN INSUFFICIENT NICK AND SPREAD. 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. THE PT WAS DESCRIBED AS HEAVILY SCARRED AND OBESE. BOTH CONDITIONS LIKELY PLACED A SIGNIFICANT ROLE IN THE DEVICE'S PERFORMANCE. 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 ACHIEVED ARTERIOTOMY CLOSURE OF A HEAVILY SCARRED RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, RESISTANCE WAS ENCOUNTERED DURING DEVICE REMOVAL. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AN ATTEMPT WAS MADE TO USE THE ACCESS PORTS, HOWEVER, IT WAS UNSUCCESSFUL. THE STARCLOSE SE CLIP DEPLOYED IN THE INTENDED LOCATION AND ACHIEVED HEMOSTASIS. WHEN THE DEVICE WAS REMOVED, THE LOCATOR WINGS APPEARED TO BE BENT. ALL PARTS OF THE LOCATORS WINGS WERE REPORTED TO BE PRESENT AND ATTACHED TO THE DEVICE. NO ADVERSE PT EFFECTS WERE REPORTED. NO ADDITIONAL INFO 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 85015-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention