BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3942501 · Received July 17, 2014

    Report

    Report Number
    2024168-2014-04605
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    April 17, 2014
    Report Date
    June 19, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED SHEATH SPLITTING ISSUE WAS CONFIRMED. A SEARCH OF THE LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. A REVIEW OF THE COMPLAINT DATABASE FOR THIS LOT DID NOT REVEAL ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INVESTIGATION, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. THIRTEEN UNUSED, STERILE REPRESENTATIVE SAMPLES WITH THE LOT NUMBER 31021K1 WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICES PASSED WITH ACCEPTABLE RESULTS. NO MALFUNCTION OR ABNORMAL OBSERVATIONS WERE DETECTED, BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF OCCURRENCE IS AN ESTIMATED DATE AND ENTERED AS (B)(6) 2014 AS THE EXACT DATE COULD NOT BE REMEMBERED. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. 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 COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER A CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, THE CLIP WOULD NOT DEPLOY BECAUSE THE SHEATH DID NOT SPLIT CORRECTLY. THE STARCLOSE SE DEVICE WAS REMOVED FROM THE ANATOMY. HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. 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
    418047 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30814K1

    Patients

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