BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3343110 · Received September 11, 2013

    Report

    Report Number
    2024168-2013-05786
    Event Type
    Injury
    Date Received
    September 11, 2013
    Date of Event
    August 19, 2013
    Report Date
    August 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OPERATOR NOT TRAINED: THE INSTRUCTIONS FOR USE STATES UNDER THE PRECAUTIONS SECTION THAT THE STARCLOSE SE VASCULAR CLOSURE SYSTEM SHOULD BE USED ONLY BY OPERATORS TRAINED IN DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES WHO HAVE BEEN CERTIFIED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR INC. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED INCOMPLETE THUMB ADVANCER DEPLOYMENT AND DIFFICULTY REMOVING THE DEVICE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ANGIOPLASTY OF THE POPLITEAL AND TIBIAL ARTERIES, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF AN ANTEGRADE PUNCTURE OF THE COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE. REPORTEDLY, AFTER CLICKING THE STARCLOSE SE DEVICE INTO THE EXCHANGE SHEATH AND DEPLOYMENT OF THE LOCATOR WINGS AN ATTEMPT WAS MADE TO DEPLOY THE THUMB ADVANCER. HOWEVER, ABOUT A THIRD OF THE WAY THROUGH THUMB ADVANCER DEPLOYMENT SIGNIFICANT RESISTANCE WAS EXPERIENCED AND THUMB ADVANCER DEPLOYMENT COULD NOT BE CONTINUED. THE SAFETY RELEASE WAS PRESSED TO RETRACT THE LOCATOR WINGS, BUT THE LOCATOR WINGS RETRACTED PARTIALLY AND THE DEVICE REMAINED STUCK. THE DEVICE WAS CHANGED TO A FEW DIFFERENT ANGLES AND THE DEVICE WAS PULLED OUT FROM THE VESSEL. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE OPERATOR WAS REPORTEDLY NOT 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
    456104 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30605K1

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention SHEATH: 5-FRENCH HEPARIN