BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3884331 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03934
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE IS NOT RETURNING. 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 REPORT FILED, ADDITIONAL INFORMATION WAS RECEIVED: THE STARCLOSE SE CLIP WAS DEPLOYED BUT DID NOT ACHIEVE HEMOSTASIS. A FEMSTOP DEVICE WAS USED TO ACHIEVE HEMOSTASIS.

    Description of Event or Problem · 1

    RECEIVED USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "EVENT DESC: PER THE PROCEDURE LOG, FOLLOWING REMOVAL OF THE ARTERIAL SHEATH, THE ABBOTT STARCLOSE CLOSURE DEVICE WAS INSERTED AND DEPLOYED. DOCUMENTATION ENTERED TEN MINUTES AFTER DEPLOYMENT NOTES THAT THE STARCLOSE ATTEMPT HAD FAILED. A FEMOSTOP WAS APPLIED TO THE SITE. THE DEVICE WAS SECURED AT THE POINT. CONTINUOUS ASSESSMENT OF THE PATIENT REVEALED NO SUBSEQUENT BLEEDING OR EVIDENCE OF A HEMATOMA. PER MATERIALS MANAGEMENT, THE DEVICE WAS RETURNED TO THE MANUFACTURER. HOWEVER, THE DATE IS NOT KNOWN BY THIS DEPARTMENT AT THIS TIME. ACCORDING TO THE PHYSICIAN, THE PRODUCT FAILED AND HE WANTS THE PRODUCT EVALUATED BY ABBOTT VASCULAR, INC. OTHER THERAPIES: ANTICOAGULANTS ARE ROUTINELY USED DURING THESE TYPES OF PROCEDURES. WHETHER THIS MEDICATION CAN EFFECT THE PERFORMANCE OF A STARCLOSE DEVICE IS LEFT FOR THE EXPERT OPINION." SUBSEQUENTLY THE REPORTER WAS CONTACTED, WHO CONFIRMED THAT THE DEVICE IS NOT RETURNING TO ABBOTT VASCULAR. THE ARTERIOTOMY CLOSURE SITE WAS THE RIGHT FEMORAL ARTERY. SHEATH SIZE WAS 6F. THE PATIENT HAD BEEN ANTICOAGULATED WITH HEPARIN. THE PHYSICIAN IS REPORTEDLY TRAINED IN USE OF THE STARCLOSE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360106 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 31204K1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SHEATH: 6F TERUMO, HEPARIN