BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE TRIMMER

    MDR report key: 1936124 · Received December 22, 2010

    Report

    Report Number
    2953144-2010-03342
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE PERCLOSE PROGLIDE (12673-03/940016H), INDICATED IS BEING FILED UNDER A SEPARATE MFR#.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONALLY, WHEN THE SCALPEL WAS USED TO TRIM THE SUTURE, IT NICKED THE TECHNICIAN'S FINGER, WHILE HE WAS APPLYING MANUAL COMPRESSION THE TARGET GROIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, DURING SUTURE HARVESTING, THE KNOT WAS FORMED 2-3 INCHES OUTSIDE THE PATIENT'S ANATOMY AND,THEREFORE, COULD NOT BE ADVANCED. A SUTURE TRIMMER WAS UNSUCCESSFULLY USED TO CUT THE SUTURES. THE SUTURES WERE CUT USING A SCALPEL AND WERE REMOVED. A NON-ABBOTT DEVICE AND MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE TRIMMER SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEVICE #1 PERCLOSE PROGLIDE (12673-03/940016H)