BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 6616842 · Received June 6, 2017

    Report

    Report Number
    2024168-2017-04828
    Event Type
    Injury
    Date Received
    June 6, 2017
    Date of Event
    May 19, 2017
    Report Date
    August 24, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO DEPLOY THE THUMB ADVANCER WAS CONFIRMED. THE REPORTED DIFFICULTY AND SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ADDITIONALLY, RETURNED, UNUSED, STERILE STARCLOSE SE DEVICES WERE SUCCESSFULLY TESTED AND NO MALFUNCTION WAS NOTED. (B)(4). [MW 5069986 (B)(4) VOLUNTARY EVENT REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE WITH A 6F SHEATH AFTER AN INTERVENTIONAL NEUROLOGICAL PROCEDURE. REPORTEDLY, THE STARCLOSE SE SHEATH WOULD NOT SPLIT COMPLETELY. WHEN RESISTANCE TO ADVANCEMENT OF THE STARCLOSE SE THUMB ADVANCER WAS FELT, THE SAFETY RELEASE MECHANISM WAS USED TO REMOVE THE STARCLOSE SE DEVICE. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY 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 FILED, USER FACILITY MEDWATCH (MW5069986) RECEIVED, STATING: ABBOTT VASCULAR CLOSURE DEVICE (STARCLOSE LOT # 7030241) DID NOT DEPLOY CORRECTLY WHEN USED BY THE ATTENDING MD. DESCRIBED AS THE SHEATH NOT SPLITTING AS IT SHOULD. NO VASCULAR CLOSURE DEVICE WAS IMPLANTED AND MANUAL PRESSURE WAS HELD BY THE ATTENDING. THE PT WAS BEING ADMITTED BUT WAS NOT ANTICOAGULATED WITH TPA AND REOPRO, SO ADD'L MONITORING FOR BLEEDING WAS REQUIRED ON ADMISSION SINCE NO VASCULAR CLOSURE DEVICE COULD BE USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397511 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 7030241

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention