BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1133182 · Received August 22, 2008

    Report

    Report Number
    2953144-2008-01372
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. (AGAINST IFU): THE PERCLOSE A-T INSTRUCTIONS FOR USE (IFU) STATE, "THE OPERATOR SHOULD THEN REMOVE THE WIRE AND USE THE SNARED KNOT PUSHER OR SUTURE TRIMMER TO ADVANCE AND TIGHTEEN THE KNOT FURTHER UNTIL COMPLETE CLOSURE IS ACHIEVED." DEVICE #2, #3 AND #4 PERCLOSE A-TS PART# 12337-05, LOT# 66007-6H, ARE BIENG FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS.

    Description of Event or Problem · 1

    DEVICE #1: MALFUNCTION: NONE. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN UNTRAINED IN THE USE OF THE PERCLOSE A-T DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED CALCIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE SUTURE THE KNOT COULD NOT BE ADVANCED TO THE ARTERY DUE TO THE USER DISCARDING THE KNOT PUSHER. THE DEVICE WAS REMOVED AND A SECOND PERCLOSE A-T WAS USED WITH THE SAME RESULTS. A THIRD PERCLOSE A-T DEVICE DID NOT DEPLOY CORRECTLY REPORTEDLY DUE TO CALCIFICATION. A FOURTH PERCLOSE A-T DEVICE THE KNOT DID NOT HOLD AT THE PUNCTURE SITE. IT WAS NOT SPECIFIED HOW HEMOSTASIS WAS ACHIEVED. THERE WERE NO REPORTED PT ADVERSE EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 66007-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DEVICE #2 PERCLOSE A-T PART # 12337-05| DEVICE #3 PERCLOSE A-T PART # 12337-05| LOT #66007-6H| LOT #66007-6H| LOT #66007-6H| DEVICE #4 PERCLOSE A-T PART # 12337-05