BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3870805 · Received June 12, 2014

    Report

    Report Number
    2024168-2014-03790
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 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
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED FAILURE TO DEPLOY THE VESSEL LOCATOR WINGS WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, THERE IS NOT AN INDICATION OF A PRODUCT DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE FAILURE TO DEPLOY THE VESSEL LOCATOR WINGS IT WAS NOTED THAT THE USE OF THE DEVICE IN THE CALCIFIED TISSUE MAY HAVE EXCEEDED THE DEVICES DESIGN LIMITS AND CAUSED THE CARRIAGE TO DISBAND FROM THE OBTURATOR SHAFT. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4) - PATIENT SELECTION. THE STARCLOSE SE DEVICE WAS DEPLOYED IN A MILDLY CALCIFIED ARTERY. PER THE INSTRUCTIONS FOR USE - DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE WITH A 6F SHEATH AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. REPORTEDLY, THE PLUNGER COULD NOT FULLY DEPRESS, THEREFORE THE LOCATOR WINGS COULD NOT BE DEPLOYED. THE STARCLOSE SE DEVICE WAS REMOVED FROM THE ANATOMY AND HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION. THE PATIENT ALSO RECEIVED A THROMBIN INJECTION. 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
    347631 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 40219K1

    Patients

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