BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851795 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02272
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    March 21, 2010
    Report Date
    April 2, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND THE VESSEL LOCATOR WINGS BROKEN, WHICH IS CONSISTENT WITH DIFFERENT DEVICE REMOVAL. EXAMINATION OF THE VESSEL LOCATOR ASSEMBLY DETERMINED ALL LOCATOR WING MATERIAL HAD BEEN RETURNED AND ALL WING ATTACHMENT POINTS WERE SECURE WITHIN THE VESSEL LOCATOR. A POSSIBLE CAUSE FOR THE DAMAGED LOCATOR WINGS MAY HAVE BEEN 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. HOWEVER, NO ANATOMICAL INFO WAS SUPPLIED. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE DAMAGED LOCATOR WINGS CONDITION IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. 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 THE LEFT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE DEVICE WAS REMOVED WITH COUNTER-TRACTION AND AN ASSERTIVE PULL. THE CLIP FROM THE STARCLOSE SE ACHIEVED HEMOSTASIS. 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 86002-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention