BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2073168 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03023
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A FEMORAL ANGIOGRAM WAS NOT TAKEN. PER THE INSTRUCTIONS FOR USE, A FEMORAL ANGIOGRAM IS TO BE PERFORMED THROUGH THE SIDE PORT OF THE PROCEDURAL SHEATH TO DETERMINE THE LOCATION OF THE ARTERIOTOMY SITE, THE VESSEL SIZE, AND THE PRESENCE OF DISEASE, TORTUOSITY, OR PRESENCE OF ARTERIAL WALL DISSECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. FEMORAL ANGIOGRAM NOT TAKEN. ESTIMATED DATE OF PROCEDURE (CLIP DEPLOYMENT OCCURRED 2 TO 3 DAYS PRIOR REPORTED (B)(6), 2011 EVENT) RETURN OF THE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED EVENT. BASED ON THE INFORMATION RECEIVED WITH THIS EVENT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE CANNOT BE DETERMINED. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT REPORTED. A SAMPLING OF FINISHED DEVICES IS TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE DURING MANUFACTURING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, TWO TO THREE DAYS AFTER DEPLOYMENT OF THE CLIP AND HEMOSTASIS WAS ACHIEVED, THE PATIENT REPORTED AN UNSPECIFIED PROBLEM IN THE LEFT LEG WHERE AN UNSUCCESSFUL CANNULIZATION HAD OCCURRED BEFORE THE DIAGNOSTIC PROCEDURE. AFTER AN ULTRASOUND AND DOPPLER WERE PERFORMED ON BOTH THE LEFT AND RIGHT LEG, AN INFECTION AND THROMBUS WAS FOUND IN THE LEFT LEG AND THE CLIP IN THE RIGHT LEG APPEARED TO BE PARTIALLY IN THE LUMEN OF THE ARTERY. THE CLIP WAS SURGICALLY REMOVED AND AN UNSPECIFIED TREATMENT WAS PROVIDED FOR THE INFECTION AND THROMBUS FOUND IN THE LEFT LEG. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, 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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention