BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2001737 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01211
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. (B)(4) - INDICATION FOR USE. THE DEVICE WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE AT DEVICE ATTEMPTED ARTERIOTOMY CLOSURE USING A PRECLOSE TECHNIQUE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE IN WHICH AN 18F SHEATH WAS USED. REPORTEDLY, THE SUTURES OF TWO DEVICES WERE SUCCESSFULLY DEPLOYED AND AFTER THE INTERVENTIONAL PROCEDURE, DURING CLOSING, A SUTURE ON ONE DEVICE BROKE. TWO ADDITIONAL PERCLOSE AT DEVICES WERE ATTEMPTED TO BE DEPLOYED; BOTH RESULTED IN A CUFF MISS. ANOTHER PERCLOSE AT DEVICE WAS SUCCESSFULLY DEPLOYED AND HEMOSTASIS WAS ACHIEVED USING THE TWO PERCLOSE AT DEVICES. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 940146H

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention PERCLOSE AT SUTURES