BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3243343 · Received July 23, 2013

    Report

    Report Number
    2024168-2013-04616
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 2, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED CONDITION CONFIRMED THE REPORTED FAILURE TO ENGAGE THE DEVICE WITH THE EXCHANGE SHEATH. BASED ON THE MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, THE PROBABLE CAUSE FOR BENT CUTTER IS INCORRECT SHEATH-TO-DEVICE INSTALLATION TECHNIQUE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL 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 WITH A 6FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE CLIP APPLIER OF THE STARCLOSE SE DEVICE WOULD NOT CONNECT TO THE EXCHANGE SHEATH HUB. 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
    342588 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30315K1

    Patients

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