BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSER TSL6 FRENCH

    MDR report key: 294122 · Received August 30, 2000

    Report

    Report Number
    2953144-2000-00146
    Event Type
    Injury
    Date Received
    August 30, 2000
    Date of Event
    July 24, 2000
    Report Date
    August 2, 2000
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT A DIAGNOSITC PROCEDURE FOLLOWING A CEREBRAL EVENT ON 07/24/00. THE ARTERIOTOMY WAS SUCCESSFULLY CLOSED WITH THE CLOSER TSL 6 FR DEVICE. THE PT EXPERIENCED BLEEDING FROM THE NOSE SUBCUTANEOUS TRACT AND THE INTERNATIONAL NORMALIZED RATIO WAS NOTED TO BE 3.7 AT THIS TIME. IT IS REPORTED THAT THE PT VISITED PT'S OWN PHYSICIAN ON 07/27/00, BUT CO DOES NOT HAVE ANY INFO FROM THE VISIT. ON 07/30/00 THE PT PRESENTED AT THE HOSP WITH A FEVER AND TENDERNESS IN THE GROIN. AN ULTRASOUND REVEALED A 2 CM PSEUDOANEURYSM. THE PT WAS TAKEN TO SURGERY AND THE AREA WAS REPAIRED WITH A PATCH GRAFT. A POCKET OF PUS WAS NOTED AT THE PSEUDOANEURYSM SITE. CULTURES OF THE SITE PRODUCED STAPH. AUREUS WHICH WAS SENSITIVE TO METHICILLIN. THE PT WAS DISCHARGED 08/07/00 ON IV ANTIBIOTICS VIA A CENTRAL LINE. NOTES FROM THE FIELD INDICATE THE PT HAS LUPUS AND IS TAKING PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSER TSL6 FRENCH SUTURE MEDIATED CLOSURE MGB PERCLOSE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention MEDICATION AND PREDNISONE.| PT RECEIVING UNSPECIFIED ANTICOAGULATION