BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER, 7F, 100CM

    MDR report key: 3872167 · Received June 13, 2014

    Report

    Report Number
    2183870-2014-00133
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COVIDIEN, LLC
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN PLYMOUTH LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION PERFORMED ON (B)(4), REVEALED THAT TEMPERATURE RISES AND REACHES OPERATING TEMPERATURE IN FIVE SECONDS, AND DEVICE COMPLETES TREATMENT CYCLE WITHOUT GENERATING ADVISORY MESSAGE. THE RETURNED DEVICE EXHIBITED NO ABNORMALITY OR DEFORMITY AND WAS ABLE TO REACH OPERATING TEMPERATURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IN THE INITAL COMPLAINT CUSTOMER STATES THAT DURING SETUP, THE PHYSICIAN FOUND THE TEMPETURE WAS NOT HIGH ENOUGH BUT USED THE SAME CATHETER TO COMPLETE THE CASE. HOWEVER, THE VEIN WAS NOT FULLY CLOSED BY THE CATHETER. THE PATIENT WAS NOT INJURED DURING THE PROCEDURE. NO SECOND CATHETER WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350152 CLOSUREFAST CATHETER, 7F, 100CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN, LLC CF7-7-100 551998

    Patients

    Seq Age Sex Outcome Treatment
    1 Other