BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 6872362 · Received September 18, 2017

    Report

    Report Number
    2024168-2017-07518
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS, WHICH WOULD HAVE AIDED IN DETERMINATION OF THE ROOT CAUSE. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: CLOSURE WAS ATTEMPTED AFTER A PULMONARY ARTERY EMBOLISM INTERVENTIONAL PROCEDURE.

    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 WITH A 6FR SHEATH AFTER AN INTERVENTIONAL 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. THE STARCLOSE SE ACHIEVED HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY NOT 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
    651927 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 7031441

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR