BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851768 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02232
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    January 9, 2010
    Report Date
    January 11, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION FOUND THE DEVICE WAS FULLY CLIP DEPLOYED. THE VESSEL LOCATOR WAS RETRACTED INTO THE DISTAL END OF THE DELIVERY TUBE WITH DAMAGED LOCATOR WINGS VISIBLE. THERE WAS NO DETECTED EXTERNAL DAMAGE TO THE DEVICE. INTERNAL EXAMINATION OF THE HANDLE AND ITS COMPONENTS DID NOT UNCOVER ANY ANOMALY. THE ACCESS PORT RELEASE FEATURE WAS INSPECTED AND THERE WAS NO OBSTRUCTION TO PREVENT ITS OPERATION. EXAMINATION OF THE DAMAGED LOCATOR WINGS DETERMINED THAT ALL OF THE WING MATERIAL WAS RETURNED AND ALL FOUR WING ATTACHMENT POINTS WITHIN THE VESSEL LOCATOR ASSEMBLY WERE SECURE. A POSSIBLE, THOUGH UNCONFIRMED 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 DEPLOYMENT TUBE SET THROUGH THE TISSUE TRACT. THIS CAN COMPACT SUBCUTANEOUS 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. IT IS NOTED WITHIN THE COMPLAINT FILE THAT THE PT DID HAVE A PRIOR ARTERIOTOMY IN THE TARGET GROIN, PRIOR DEVICE CLOSURE IN THE TARGET GROIN AND PERIPHERAL VASCULAR DISEASE. ALL OF THESE CONDITIONS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO OTHER ABNORMALITY OR MANUFACTURING/QUALITY ISSUE WAS DETECTED AND THE LOT HISTORY REVIEW DID NOT PRODUCE ANY INFO RELEVANT TO THE REPORT. BASED ON THE INVESTIGATION, THE ROOT CAUSE FOR THE COMPLAINT IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE LOCATOR WINGS FAILED TO RETRACT. AFTER SOME MANIPULATION THE LOCATOR WINGS RETRACTED AND THE STARCLOSE SE DEVICE WAS REMOVED FROM THE PT ANATOMY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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 820246-H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention