BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851541 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02069
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 28, 2008
    Report Date
    September 4, 2008
    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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE REVEALED THE DEVICE TO BE FULLY CLIP DEPLOYED WITH BENT AND BROKEN LOCATOR WINGS AND A DISPLACED SAFETY RELEASE BUTTON/SLIDER. THE DAMAGED VESSEL LOCATOR ACCOUNTS FOR THE DIFFICULT TO REMOVE COMPLAINT. IT WAS CONFIRMED THE DILATOR ASSISTED REMOVAL TECHNIQUE WAS APPLIED TO THE DEVICE BY THE LOCATION AND ALIGNMENT OF VARIOUS DEVICE COMPONENTS. INSPECTION OF THE DAMAGED LOCATOR WINGS DETERMINED THAT ALL OF THE DAMAGED WINGS' ATTACHMENT POINTS WERE SECURE WITHIN THE VESSEL LOCATOR ASSEMBLY AND THE BROKEN WINGS WERE NOT MISSING ANY OF ITS MATERIAL. THE PROBABLE, THOUGH UNCONFIRMED, ROOT CAUSE FOR THE DAMAGED CONDITION OF THE WINGS WAS LIKELY EITHER ANATOMICAL OR PROCEDURAL. PROCEDURALLY, A DISTAL PRESSURE CAN BE APPLIED TO THE DEPLOYED VESSEL LOCATOR WINGS DURING THE DISTAL DEPLOYMENT OF THE THUMB ADVANCER/DELIVERY TUBE. THE DISTAL MOVEMENT OF THE DELIVERY TUBE THROUGH THE TISSUE TRACT PUSHES THE TUBE INTO THE VESSEL LOCATOR PUSHING ITS WINGS DISTALLY, COMPACTING THE TISSUE BETWEEN THE LOCATOR WINGS AND THE DISTAL END OF THE DELIVERY TUBE. THIS CONDITION THEN INHIBITS CORRECT LOCATOR WING RETRACTION INTO THE DISTAL END OF THE DELIVERY TUBE, BENDING AND IN SOME CASES CAUSING BREAKAGE OF THE LOCATOR WING(S). ANATOMICALLY, ANY FEATURE WITHIN THE BODY, SCAR TISSUE, CALCIFICATION ETC. THAT MAY INHIBIT CORRECT LOCATOR WING RETRACTION MAY HAVE BEEN ENCOUNTERED, HOWEVER, NO ANATOMICAL INFO WAS AVAILABLE OR SUPPLIED. THE DISPLACED SAFETY RELEASE BUTTON/SLIDER IS A TECHNIQUE USE ERROR. ONCE A DEVICE CLIP IS DEPLOYED, THE SAFETY RELEASE BUTTON IS NO LONGER ACCESSIBLE FOR OPERATION, ONLY A SMALL SEGMENT ON THE PROXIMAL END OF THE SAFETY RELEASE BUTTON IS VISIBLE. THE DISPLACED POSITION OF THE SAFETY BUTTON/ROD ASSEMBLY INDICATED THAT DOWNWARD PRESSURE WAS APPLIED TO THE INACCESSIBLE SAFETY BUTTON DISLODGING IT FROM ITS RETENTION FEATURES WITHIN THE HANDLE INTENDED TO HOLD THE BUTTON/ROD COMBINATION IN ITS PROPER POSITION. FURTHER INSPECTION OF THE DEVICE DID NOT PRODUCE ANY OTHER FINDINGS THAT MAY HAVE CONTRIBUTED TO THE DETECTED DAMAGE OR COMPLAINT. A REVIEW OF THE LOT HISTORY RECORD DID NOT PRODUCE ANY FINDINGS THAT WERE RELEVANT TO THIS INVESTIGATION. NO MFG OR QUALITY ISSUE WAS DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE STARCLOSE SE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH INSTRUCTIONS FOR USE A DILATOR WAS INSERTED INTO THE ACCESS PORTS TO SUCCESSFULLY REMOVE THE DEVICE FROM THE PATIENT. HEMOSTASIS WAS ACHIEVED WITH THE DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L 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 66047-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention