BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 6872450 · Received September 18, 2017

    Report

    Report Number
    2024168-2017-07519
    Event Type
    Injury
    Date Received
    September 18, 2017
    Date of Event
    August 25, 2017
    Report Date
    November 29, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. DEVICE CODE: THIS CODE IS USED TO ADDRESS THE OPERATOR NOT BEING TRAINED IN THE USE OF THE STARCLOSE SE. PER THE STARCLOSE SE INSTRUCTIONS FOR USE: THE STARCLOSE SE VASCULAR CLOSURE SYSTEM SHOULD BE USED ONLY BY OPERATORS TRAINED IN DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES WHO HAVE BEEN CERTIFIED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR INC. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. ALTHOUGH THE THUMB ADVANCER STROKE WAS RETURNED COMPLETED AND THE SHEATH WAS NOT DETACHED AS REPORTED, THE REPORTED DIFFICULTIES COULD NOT BE REPLICATED. THE REPORTED HEMOSTASIS ATTEMPTED WITH THE STARCLOSE SE CLIP WHICH HAD UNSATISFACTORY RESULTS, COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT. DIFFICULTY OR FAILURE TO DEPLOY THE CLIP APPEARS TO BE RELATED TO THE INABILITY TO FULLY SPLIT THE SHEATH. THE MOST PROBABLE CAUSE FOR THE DIFFICULT OR FAILURE TO SPLIT THE SHEATH IS RELATED TO THE MATERIAL USED TO MANUFACTURE THE SHEATH. A REVIEW OF THE COMPLAINT HANDLING DATABASE FOUND SIMILAR INCIDENTS FROM THIS LOT REPORTED FOR DIFFICULTY OR FAILURE TO SPLIT THE SHEATH. ABBOTT VASCULAR (AV) CONDUCTED ROOT CAUSE ANALYSIS AND DETERMINED THE ISSUE MAY BE RELATED TO MANUFACTURING. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. AV WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER AN INTERVENTIONAL TUMOR EMBOLISM PROCEDURE. REPORTEDLY, IT WAS DIFFICULT TO PERFORM STEP 3 (SPLITTING THE SHEATH). IT TAKES MORE STRENGTH TO TEAR THE INTRODUCER SHEATH. A PLASTIC STRIP FROM THE INTRODUCER SHEATH DETACHED FROM THE SHEATH, NO RETRIEVAL WAS NECESSARY AS IT DID NOT ENTER THE ANATOMY. HEMOSTASIS WAS ATTEMPTED WITH THE STARCLOSE SE CLIP; HOWEVER, THE RESULT WAS NOT SATISFACTORY. HEMOSTASIS WAS ACHIEVED WITH MANUAL ARTERIAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTED TO BE NOT 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
    654287 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 7041041

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SHEATH: 6FHEPARIN