BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2900355 · Received January 7, 2013

    Report

    Report Number
    2024168-2013-00137
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED FAILURE TO DEPLOY THUMB ADVANCER WAS CONFIRMED. BASED ON THE REPORTED INFORMATION, MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, PROBABLE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE, WITH A 6FR SHEATH, AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE SHEATH DID NOT SPLIT COMPLETELY. RESISTANCE WAS FELT HALF WAY THROUGH ADVANCEMENT. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE SAFETY RELEASE MECHANISM ACCESS PORTS WERE USED TO SUCCESSFULLY FACILITATE DEVICE REMOVAL. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6299 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 21002K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6FRANGIOMAX