BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851769 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02231
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    December 31, 2009
    Report Date
    December 31, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND THE VESSEL LOCATOR WINGS BROKEN, CONSISTENT WITH DIFFICULT DEVICE REMOVAL. ALSO DETECTED WAS A DISPLACED SAFETY RELEASE SLIDER. THE VESSEL LOCATOR WINGS WERE EXAMINED AND IT WAS DETERMINED THERE WAS NO MISSING WING MATERIAL AND ALL WING ATTACHMENT POINTS WITHIN THE VESSEL LOCATOR ASSEMBLY WERE SECURE. DAMAGED VESSEL LOCATOR WINGS ARE CONSISTENT WITH DISTAL PRESSURE APPLIED TO THE DEPLOYED LOCATOR WINGS DURING DEPLOYMENT OF THE THUMB ADVANCER/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 DEVICE 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. THE DISPLACED SLIDER WAS LIKELY USED IN ATTEMPT TO ASSIST IN THE REMOVAL OF THE DEVICE. THE SAFETY RELEASE SLIDER IS DESIGNED TO ALLOW RETRACTION OF THE VESSEL LOCATOR WINGS ONLY PRIOR TO CLIP DEPLOYMENT, NOT POST CLIP DEPLOYMENT. THE DISPLACED CONDITION INDICATED A DOWNWARD FORCE WAS APPLIED TO THE SLIDER POST CLIP DEPLOYMENT DISPLACING IT INTO THE HANDLE. THERE WAS NO DEFECT OR DAMAGE TO THE ACCESS PORT MECHANISM. DURING DEVICE TESTING, THE THUMB ADVANCER/DELIVERY TUBE SET ASSEMBLY WAS RETRACTED PROXIMALLY WITHIN THE HANDLE OF THE DEVICE AFTER A DILATOR WAS INSERTED INTO THE ACCESS PORTS TO UNLOCK THE THUMB ADVANCER. NO OTHER OBSERVATIONS WERE DETECTED. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE REPORTED EVENT AND THE DAMAGED CONDITION OF THE DEVICE 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 THE PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PT'S ARTERY. IN ACCORDANCE WITH INSTRUCTIONS FOR USE, AN ATTEMPT WAS MADE TO USE THE ACCESS PORTS, HOWEVER, IT WAS UNSUCCESSFUL. THE DEVICE WAS ULTIMATELY REMOVED USING COUNTER-TRACTION AND ASSERTIVE PULL. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. 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 82016-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention