BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3180655 · Received June 20, 2013

    Report

    Report Number
    2024168-2013-03835
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THE OTHER STARCLOSE SE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. (B)(4) - OPERATOR NOT TRAINED. PER THE INSTRUCTIONS FOR USE, UNDER CAUTION - THIS DEVICE SHOULD ONLY BE USED BY PHYSICIANS (OR OTHER HEALTHCARE PROFESSIONALS AUTHORIZED BY OR UNDER THE DIRECTION OF SUCH PHYSICIANS) WHO ARE TRAINED IN DIAGNOSTIC AND THERAPEUTIC CATHETERIZATION PROCEDURES AND WHO HAVE BEEN TRAINED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON THE VISUAL INSPECTION AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE DEPLOYMENT SEQUENCE WAS INCORRECT PER THE INSTRUCTIONS FOR USE (IFU) UNDER CLOSURE PROCEDURE SECTION, WHICH INSTRUCTS THE OPERATOR TO ENGAGE THE EXCHANGE SHEATH WITH THE DEVICE, THEN DEPLOY THE PLUNGER TO ADVANCE THE THUMB ADVANCER AND DELIVERY TUBESET. ALSO, PER THE INSTRUCTIONS FOR USE, UNDER CAUTION - THIS DEVICE SHOULD ONLY BE USED BY PHYSICIANS (OR OTHER HEALTHCARE PROFESSIONALS AUTHORIZED BY OR UNDER THE DIRECTION OF SUCH PHYSICIANS) WHO ARE TRAINED IN DIAGNOSTIC AND THERAPEUTIC CATHETERIZATION PROCEDURES AND WHO HAVE BEEN TRAINED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE DEVICE AFTER A PERIPHERAL INTERVENTIONAL PROCEDURE, USING A 6F SHEATH. REPORTEDLY, THE DEVICE WOULD NOT CLICK INTO THE EXCHANGE SHEATH. EXAMINATION OF THE DEVICE AFTER THE INCIDENT SHOWED THAT THE PLUNGER HAD BEEN PARTIALLY DEPRESSED. A SECOND STARCLOSE DEVICE WAS USED AND REPORTEDLY THE SHEATH DID NOT SPLIT PROPERLY. HEMOSTASIS WAS ACHIEVED BY APPLYING MANUAL ARTERIAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY NOT TRAINED IN THE USE OF THE STARCLOSE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280722 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30417K1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SHEATH: 6F HEPARIN