BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE TRIMMER KP+T

    MDR report key: 367986 · Received December 21, 2001

    Report

    Report Number
    2953144-2001-00248
    Event Type
    Injury
    Date Received
    December 21, 2001
    Date of Event
    November 20, 2001
    Report Date
    November 26, 2001
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ACHIEVED ARTERIOTOMY CLOSURE WITH THE CLOSER S DEVICE FOLLOWING AN INTERVENTION PROCEDURE. UPON ATTEMPTED RETRACTION OF THE GATED KNOT POSITIONER/SUTURE TRIMMER AFTER CUTTING THE SUTURE, THE DEVICE SNAGGED ON SUBCUTANEOUS TISSUE. REPEATED ENDEAVORS TO INITIALLY FREE THE SUTURE TRIMMER WERE UNSUCCESSFUL, BUT A SUBSEQUENT EFFORT ALLOWED THE DEVICE TO COME FREE. THE OPERATOR NOTED THAT THE DISTAL BLACK TIP OF THE SUTURE TRIMMER WAS MISSING AND PRESUMABLY LEFT IN THE SUBCUTANEOUS TISSUE. THE PHYSICIAN ADMINISTERED ANTIBIOTICS PROPHYLACTICALLY AND UPON CONSULTATION WITH A VASCULAR SURGEON, DECIDED TO PURSUE NO RETRIEVAL ACTION AND TO MONITOR THE SITUATION WITH THE PT OVER THE NEXT FEW WEEKS AND MONTHS AS NECESSARY. NO FURTHER INJURY TO THE PT HAS BEEN REPORTED SINCE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58216 SUTURE TRIMMER KP+T KNOT PUSHER WITH SUTURE TRIMMER MGB PERCLOSE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention UNKNOWN PROPHYLACTIC ANTIBIOTICS.