BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3142923 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03453
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EXCHANGE SHEATH SPLITTING ISSUE 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE SAFETY RELEASE MECHANISM WAS NOT UTILIZED TO REMOVE THE DEVICE. THE STARCLOSE SE INSTRUCTIONS FOR USE STATES UNDER CLOSURE PROCEDURE THAT IF EXCESSIVE RESISTANCE IS EXPERIENCED DURING ADVANCEMENT OF THE THUMB ADVANCER, MANUALLY COLLAPSE THE LOCATOR WINGS AND REMOVE THE DEVICE FOLLOWING THE STEPS BELOW. RETRACT THE THUMB ADVANCER AS FAR PROXIMAL AS POSSIBLE UNTIL RESISTANCE IS FELT. THIS IS TO DECREASE ANY INTERACTION BETWEEN THE CLIP DELIVERY TUBE AND THE FLEX-GUIDE. SLIDE THE SAFETY RELEASE TO COLLAPSE THE LOCATOR WINGS. THE LOCATOR WINGS ARE FULLY COLLAPSED WHEN THE NUMBER TWO ON THE PLUNGER EXITS THE NUMBER WINDOW COMPLETELY. PLACE THE LEFT HAND ON THE PUNCTURE SITE IN THE PALM-DOWN POSITION WITH THE CLIP DELIVERY TUBE EXTENDING UP BETWEEN THE INDEX AND MIDDLE FINGER. PROVIDE COUNTER-TRACTION WITH THE LEFT HAND ON THE BODY OF THE PATIENT, AND ASSERTIVELY PULL THE DEVICE OUT WITH THE RIGHT HAND. IT IS IMPORTANT NOT TO ROCK OR TWIST THE DEVICE AS THIS MAY CAUSE ARTERIAL DAMAGE.

    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 ESTIMATED DATE OF BIRTH OF THE PATIENT WHO WAS REPORTED TO BE BORN IN 1928.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PERCUTANEOUS TRANSLUMINAL MECHANICAL THROMBECTOMY PROCEDURE, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF THE COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE. REPORTEDLY, DURING DEPLOYMENT, THE EXCHANGE SHEATH DETACHED FROM THE CLIP APPLIER. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA, BUT WAS NOT DUE TO THE REPORTED EXPERIENCE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: REPORTEDLY, THE EXCHANGE SHEATH DID NOT DETACH AS WAS INITIALLY REPORTED. HOWEVER, DURING THUMB ADVANCER/EXCHANGE SPLITTING, SPLITTING OF THE EXCHANGE SHEATH DID NOT APPEAR NORMAL. DEPLOYMENT OF THE THUMB ADVANCER WAS STOPPED AND THE DEVICE WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243274 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30415K1

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention SHEATH: 6-FRENCH