BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1828619 · Received August 27, 2010

    Report

    Report Number
    2953144-2010-01746
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    June 15, 2010
    Report Date
    August 2, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT WAS REPORTED TO BE A (B)(6) OLD FEMALE. SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE USER FACILITY (UF) REPORT SOURCE INFORMED ABBOTT VASCULAR THAT A USER FACILITY MEDWATCH REPORT THAT THEY HAD SENT TO US, WAS INCORRECTLY POPULATED WITH DATA FROM A PREVIOUSLY REPORTED EVENT. ALTHOUGH USER FACILITY MEDWATCH REPORT NUMBERS (B)(4) WERE SENT TO ABBOTT VASCULAR, THE CORRECT AND ONLY REPORT DURING THIS TIME PERIOD FOR AN ABBOTT VASCULAR DEVICE WAS DOCUMENTED IN UF REPORT NUMBER (B)(4). IT WAS CLARIFIED THAT UF REPORT NUMBER (B)(4) SHOULD HAVE INCLUDED DATA FOR A DIFFERENT EVENT THAT DID NOT INVOLVE AN ABBOTT VASCULAR DEVICE. REFERENCE TO UF REPORT NUMBER (B)(4) WAS INCLUDED IN THE INITIAL MEDWATCH 3500A REPORT SUBMITTED TO THE FDA BY ABBOTT VASCULAR. THE CORRECT UF REPORT ASSOCIATED WITH THIS EVENT IS (B)(4) WHICH IS ATTACHED TO THIS FOLLOW UP EMDR SUBMISSION. WITH THE EXCEPTION OF THE PATIENTS DEMOGRAPHIC INFORMATION (AGE AND GENDER), THE INITIAL SUBMISSION REFLECTS THE ACCURATE EVENT DETAILS.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES "EVENT DESC: THE CLOSURE DEVICE DID NOT DEPLOY." CUSTOMER REPORT SOURCE CONTACTED AND THE FOLLOWING ADDITIONAL INFO WAS RECEIVED. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. ARTERIOTOMY CLOSURE WAS ATTEMPTED OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT NA 88042-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention PROCEDURAL SHEATH 6F