BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE TRIMMER

    MDR report key: 1851791 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02342
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE SUTURE TRIMMER WAS RECEIVED UNDAMAGED. AFTER THE DRIED BLOOD AND TISSUE WERE CLEANED FROM THE DISTAL END OF THE TRIMMER, THE ACCESSORY WAS TESTED WITH SUTURE FROM A PROXY PROGLIDE DEVICE. DURING TESTING, THE SUTURE WAS CAPTURED AND HELD AT THE DISTAL END OF THE SLIDER, THE LEVER WAS ACTIVATED, WHICH CUT THE SUTURE WITHOUT DIFFICULTY. THERE WAS NO DAMAGE OR ABNORMALITY DETECTED DURING TESTING THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. BASED ON THE EVAL FINDINGS, THE ROOT CAUSE FOR THE FAILURE OF THE SUTURE TRIMMER TO CUT THE SUTURE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER ADVANCING THE KNOT TO THE ARTERIAL SURFACE, THE SUTURE COULD NOT BE CUT WITH THE SUTURE TRIMMER. A SECOND SUTURE TRIMMER WAS USED TO CUT THE SUTURE. HEMOSTASIS WAS ACHIEVED WITH THE PROGLIDE DEVICE SUTURE. NO ADVERSE PT EFFECTS WERE REPORTED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE TRIMMER MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 89010-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention