BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851776 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02221
    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 FOUND THE CLIP FULLY DEPLOYED. THE DEVICE WAS NOT IN THE ACCESS PORT ACTIVATED RELEASED STATE. FLEX GUIDE OR SHAFT CARVING, ORIGINATING AT THE FLEX GUIDE'S PROXIMAL END, AND DAMAGED VESSEL LOCATOR WINGS WERE OBSERVED. ALSO NOTED WAS A DAMAGED CLIP DELIVERY TUBE AND EXCHANGE SHEATH. IT WAS DETERMINED THE DAMAGED DELIVERY TUBE AND SHEATH WERE DUE TO THE EFFECTS OF THE CARVING PROCESS AND NOT RELATED TO ANY DEVICE FAILURE. THE NOTED FLEX-GUIDE CARVING AND ITS RESULTING DEVICE COMPONENT DAMAGE IS CONSISTENT WITH A FAILURE TO MAINTAIN THE ALIGNMENT OF THE CLIP DELIVERY COMPONENTS WHILE THE PLUNGER AND/OR THUMB ADVANCER IS DISTALLY DEPLOYED. THIS RESULTS IN THE DISTAL END OF THE DELIVERY TUBE CARVING INTO THE SHAFT'S OUTER NYLON MATERIAL AND IN THIS CASE ALSO THE EXCHANGE SHEATH, DAMAGING THE CLIP DELIVERY TUBE IN THE PROCESS. 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. EXAMINATION OF THE LOCATOR WINGS DETERMINED THEY WERE STILL SECURE IN THEIR ATTACHMENT TO THE VESSEL LOCATOR ASSEMBLY, AND THERE WAS NO MISSING MATERIAL FROM THE BROKEN WING SEGMENTS. 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 THE FACTS FROM THE 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 81032-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention