BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1934951 · Received December 21, 2010

    Report

    Report Number
    2953144-2010-03332
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 16, 2010
    Report Date
    December 1, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT FULLY CLIP DEPLOYED. THE EXTERNAL AND INTERNAL COMPONENTS WERE IN THE CORRECT POST DEPLOYED POSITIONS AND UNDAMAGED. THERE WAS NO DAMAGE OR ABNORMALITIES DETECTED THAT WOULD HAVE CONTRIBUTED TO THE REPORT OF THE CLIP NOT TAKING. BASED ON THE ANALYSIS OF THE DEVICE THE REPORTED EVENT COULD NOT BE CONFIRMED. CAUSES FOR THE CLIP NOT TAKING OR CLOSING THE SITE DUE TO RETRACTION DURING CLIP DEPLOYMENT WHICH WILL RESULT IN CLIP DEPLOYMENT ABOVE THE ARTERY OR A PARTIAL CAPTURE ARE THE OPERATOR NOT MAINTAINING DOWNWARD PRESSURE OR NOT MAINTAINING A 60 TO 75 DEGREE ANGLE DURING CLIP DEPLOYMENT. THERE WAS NO MANUFACTURING OR QUALITY ISSUES DETECTED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE "CLIP DID NOT TAKE" AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-REDWOOD CITY 920176H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention