BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSER - TSL6

    MDR report key: 265264 · Received January 24, 2000

    Report

    Report Number
    2953144-2000-00016
    Event Type
    Injury
    Date Received
    January 24, 2000
    Date of Event
    January 5, 2000
    Report Date
    January 24, 2000
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT A DIAGNOSTIC PROCEDURE. THE PUNCTURE WAS MEDIAL, IN THE COMMON FEMORAL ARTERY. THE PHYSICIAN CLOSED THE ARTERIOTOMY WITH THE CLOSER TSL 6 FR. DEVICE. THE PT WAS DISCHARGED FROM THE HOSP AND RETURNED 01/14/2000 PRESENTING WITH CLAUDICATION AND WEAK PULSES. AN ANGIOGRAM DEMONSTRATED THAT AN INTIMAL FLAP POSTERIOR TO THE ARTERIOTOMY HAD BEEN STITCHED TO THE ARTERIOTOMY. THE ARTERY WAS SURGICALLY REPAIRED ON 01/14/2000. THE PT RECOVERED WITHOUT FURTHER INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention NONE REPORTED.