BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851775 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02222
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    December 10, 2009
    Report Date
    December 11, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE CONFIRMED THE CLIP WAS FULLY DEPLOYED AND WAS NOT IN THE ACCESS PORT ACTIVATED RELEASE STATE. BROKEN VESSEL LOCATOR WINGS AND A DISPLACED SAFETY RELEASE WERE DETECTED. INSPECTION OF THE BROKEN LOCATOR WINGS DETERMINED THAT ALL OF THE WING MATERIAL WAS RETURNED AND THE ATTACHMENT POINTS OF THE LOCATOR WINGS WITHIN THE VESSEL LOCATOR ASSEMBLY WERE SECURE. A POSSIBLE CAUSE FOR THE DAMAGED VESSEL LOCATOR WINGS MAY HAVE BEEN PROCEDURAL OR ANATOMICAL. 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 INFO WAS SUPPLIED. THE DISPLACED CONDITION OF THE SAFETY RELEASE BUTTON INDICATED THE BUTTON HAD BEEN PUSHED DOWNWARD POST CLIP DEPLOYMENT IN AN ATTEMPT TO FACILITATE THE STUCK DEVICE'S REMOVAL FROM THE PT. THE SAFETY RELEASE BUTTON FEATURE IS ONLY FUNCTIONAL PRIOR TO CLIP DEPLOYMENT. POST CLIP DEPLOYMENT THE SAFETY RELEASE FEATURE IS INOPERATIVE. THIS IS NOT CONSIDERED A FAILURE MODE, ONLY AN OBSERVATION AS A STUCK DEVICE'S REMOVAL MAY REQUIRE ANY MEANS NECESSARY. INTERNAL EXAMINATION OF THE DEVICE DID NOT DETECT ANY ABNORMALITY THAT MAY HAVE PREVENTED THE ACTIVATION AND OPERATION OF THE ACCESS PORT RELEASE MECHANISM. LAB TESTING WAS CONDUCTED TO TEST THE FUNCTION OF THE ACCESS PORT MECHANISM AND THE TESTING WAS SUCCESSFUL WITH PROXIMAL RETRACTION OF THE THUMB ADVANCER AND DELIVERY TUBE OCCURRING WITHOUT ANY DETECTED RESISTANCE. NO OTHER DEVICE ANOMALIES WERE NOTED DURING THE INVESTIGATION. THERE WAS NO DETECTED MFG OR QUALITY ISSUE WITH THE RETURNED DEVICE AND THE LOT HISTORY REVIEW DID NOT PRODUCE ANY INFO RELEVANT TO THIS REPORT. BASED ON INVESTIGATION OF THIS EVENT THE ROOT CAUSE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. ADDITIONALLY, 3 STERILE UNUSED DEVICES FROM THE SAME LOT WERE RECEIVED AND WERE FUNCTIONALLY TESTED. THE DEVICES PASSED FUNCTIONAL TESTING WITH ACCEPTABLE RESULTS. NO MFG OR QUALITY ISSUE WAS DETECTED.

    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 AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PT'S ARTERY. IN ACCORDANCE WITH THE 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 780306H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention