BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2831620 · Received November 14, 2012

    Report

    Report Number
    2024168-2012-07169
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    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. THE ANALYSIS OF THE RETURNED DEVICE DID NOT CONFIRM THE REPORTED EXPERIENCE. THE DEVICE WAS RECEIVED IN THE PARTIALLY DEPLOYED CONDITION. THE PLUNGER WAS DEPLOYED, THE THUMB ADVANCER WAS JUST PROXIMAL TO STARTING POSITION, THE SHEATH COMPLETELY SPLIT, THE TUBE SET WAS IN DEPLOYED ALIGNMENT, AND THE VESSEL LOCATOR WINGS (VLW) DEPLOYED. THERE WAS NO OTHER ANOMALY OBSERVED. THE SAFETY RELEASE WAS ACTIVATED AND THE VLW COLLAPSED AS INTENDED. THE HANDLE WAS OPENED AND THE TUBE SET CAN BE VERIFIED TO BE IN DEPLOYED ALIGNMENT. THE CLIP WAS NOT ON THE DEVICE AND ITS LOCATION IS UNKNOWN. THE CAUSE FOR THE REPORTED EXPERIENCE CANNOT BE DETERMINED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED DATE OF OCCURRENCE, EXACT DATE WAS NOT RECALLED. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING A STARCLOSE SE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, IT DID NOT DEPLOY. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT REPORTED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. AS THE NAME OF THE PHYSICIAN WAS NOT PROVIDED BY THE HOSPITAL, IT IS UNKNOWN IF THE PHYSICIAN HAS BEEN 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
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 20817K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention