BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 4251872 · Received November 14, 2014

    Report

    Report Number
    2024168-2014-07462
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE STARCLOSE SE INSTRUCTIONS FOR USE (IFU) STATES UNDER WARNINGS TO PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. IN ADDITION, THE IFU STATES UNDER CLOSURE PROCEDURE TO PERFORM A FEMORAL ANGIOGRAM THROUGH THE SIDE PORT OF THE PROCEDURAL SHEATH TO DETERMINE THE LOCATION OF THE ARTERIOTOMY SITE, THE VESSEL SIZE, AND THE PRESENCE OF DISEASE (CALCIFIED PLAQUE, STENOSIS, CHRONIC OR ACUTE OCCLUSION), TORTUOSITY OR PRESENCE OF ARTERIAL WALL DISSECTION. ESTIMATED DATE OF EVENT - ALTHOUGH THE DATE OF OCCURRENCE WAS REQUESTED, IT HAS NOT YET BEEN PROVIDED. THE CUSTOMER REPORTED THAT THE PRODUCT EXPERIENCE OCCURRED BETWEEN (B)(6) 2014. THE ESTIMATED DATE OF OCCURRENCE WILL BE REPORTED AS (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EXCHANGE SHEATH CARVING WAS CONFIRMED. BASED ON VISUAL INSPECTION 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PERCUTANEOUS CORONARY INTERVENTION, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF A SLIGHTLY SCARRED COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE. REPORTEDLY, DURING THUMB ADVANCER/EXCHANGE SHEATH SPLITTING, CARVING OCCURRED. THE DEVICE WAS REMOVED AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. IT WAS BELIEVED THAT THE DEVICE CARVING WAS CAUSED DURING THUMB ADVANCER/EXCHANGE SHEATH SPLITTING DUE TO THE OPERATOR HOLDING THE STARCLOSE SE DEVICE AT AN INCORRECT ANGLE. IN ADDITION, THE STARCLOSE SE SYSTEM WAS NOT CORRECTLY PULLED BACK APPROXIMATELY ONE INCH OUT OF THE PATIENT ANATOMY BEFORE EXECUTING THUMB ADVANCER/EXCHANGE SHEATH SPLITTING AS INDICATED IN THE INSTRUCTIONS FOR USE. THE OPERATOR WAS 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
    737992 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 40513K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6-FRENCHHEPARIN