BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 6715085 · Received July 14, 2017

    Report

    Report Number
    2024168-2017-05909
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    June 22, 2017
    Report Date
    October 23, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT SELECTION, PER INSTRUCTIONS FOR USE, UNDER PRECAUTIONS: DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. 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). LOT NUMBER CHANGED FROM 7052241 TO 7032041. ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULT TO REMOVE THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT. THE REPORTED DIFFICULTY REMOVING THE DEVICE APPEARS TO BE RELATED TO USE TECHNIQUE SUCH THAT THE ACCESS POSTS WERE NOT UTILIZED TO FACILITATE DEVICE REMOVAL. THE 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 OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A CALCIFIED COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE VIA A 6FR SHEATH, AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. REPORTEDLY, THE STARCLOSE SE COULD NOT BE REMOVED FOLLOWING CLIP DEPLOYMENT. THE SAFETY RELEASE MECHANISM WERE USED TO RETRACT THE VESSEL LOCATOR WINGS AND THE DEVICE WAS REMOVED. THE CLIP OF THE STARCLOSE SE DEVICE ACHIEVED HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494395 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 7032041

    Patients

    Seq Age Sex Outcome Treatment
    1