BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3896205 · Received June 26, 2014

    Report

    Report Number
    2024168-2014-04117
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULTY TO REMOVE DEVICE WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE DID NOT REVEAL ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. REPORTEDLY, THE SAFETY RELEASE MECHANISM WAS NOT USED TO HELP FACILITATE DEVICE REMOVAL FROM THE PATIENT ANATOMY. THE INSTRUCTIONS FOR USE, STATES: IF EXCESSIVE RESISTANCE IS EXPERIENCED DURING ADVANCEMENT OF THE THUMB ADVANCER, MANUALLY COLLAPSE THE LOCATOR WINGS AND REMOVE THE DEVICE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4): FAILURE TO FOLLOW STEPS/INSTRUCTIONS, IS USED TO ADDRESS THAT THE SAFETY RELEASE MECHANISM WAS NOT USED TO FACILITATE DEVICE REMOVAL FROM THE TISSUE TRACT. THE INSTRUCTIONS FOR USE, STATES: IF EXCESSIVE RESISTANCE IS EXPERIENCED DURING ADVANCEMENT OF THE THUMB ADVANCER, MANUALLY COLLAPSE THE LOCATOR WINGS AND REMOVE THE DEVICE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    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 DEVICE WITH A 5F SHEATH AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE. THE SAFETY RELEASE MECHANISM WAS NOT USED TO HELP FACILITY DEVICE REMOVAL FROM THE TISSUE TRACT. A CUT DOWN WAS PERFORMED TO REMOVE THE STARCLOSE SE DEVICE FROM THE TISSUE TRACT. A SURGICAL SUTURE WAS USED TO CLOSE THE ARTERY AND ACHIEVE COMPLETE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE SURGICAL CUT-DOWN PROCEDURE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374557 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 40204K1

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention SHEATH: 5F, HEPARIN