BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 7697960 · Received July 18, 2018

    Report

    Report Number
    2024168-2018-05554
    Event Type
    Injury
    Date Received
    July 18, 2018
    Date of Event
    June 26, 2018
    Report Date
    September 11, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). LOT NUMBER CHANGED FROM 8010641 TO 7110741. THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULT/FAILURE TO ADVANCE THE THUMB ADVANCER, SHEATH SHREDDING AND CLIP REMAINING AT THE DISTAL END OF THE DEVICE WERE CONFIRMED. DIFFICULTY REMOVING THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES AND TREATMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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 IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    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 RELEVANT INFORMATION.

    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 VIA A 6F SHEATH AFTER AN UTERINE FIBROID EMBOLIZATION INTERVENTIONAL PROCEDURE. REPORTEDLY, THERE WAS RESISTANCE ADVANCING THE THUMB ADVANCER. THE SHEATH SPLIT COMPLETELY; HOWEVER, SHEATH SHREDDING WAS NOTED. THE CLIP DEPLOYED BUT REMAINED ON THE DISTAL END OF THE DEVICE. THERE WAS RESISTANCE REMOVING THE DEVICE FROM THE PATIENT ANATOMY. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540016 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 7110741

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SHEATH: 6F| SHEATH: 6F