BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLOSUREFAST CATHETER, 7F, 60CM

    MDR report key: 4102752 · Received September 19, 2014

    Report

    Report Number
    2183870-2014-00238
    Event Type
    Death
    Date Received
    September 19, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 20, 2014
    Manufacturer
    CM-PLYMOUTH
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, SHOULD IT BECOME AVAILABLE A SUPPLEMENT REPORT WILL BE SUBMITTED.

    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.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN THE (B)(6). A PATIENT DEATH WAS REPORTED TWO WEEKS POST PROCEDURE. A (B)(6) YEAR OLD FEMALE CALLED THE HOSPITAL WITH A PAINFUL LEG AFTER A RF VENEFIT PROCEDURE APPROXIMATELY 4 DAYS AFTER PROCEDURE. THE PATIENT WAS ADVISED TO COME INTO THE HOSPITAL AND DECLINED BUT PRESENTED THE FOLLOWING DAY, 6 DAYS POST PROCEDURE. THE PATIENT WAS SEEN BY THE PHYSICIAN AND SENT HOME BECAUSE THEY DID NOT FEEL THERE WAS A DVT/PE PRESENT. THE PATIENT RETURNED THE NEXT DAY AND WAS SENT TO A LOCAL ACUTE HOSPITAL WHERE IT WAS CONFIRMED THAT THE PATIENT HAD A PE. THE PATIENT WAS THEN STARTED ON ANTI-COAGULATION MEDICATION. HOWEVER, THE PATIENT EXPIRED DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584466 CLOSUREFAST CATHETER, 7F, 60CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CM-PLYMOUTH CF7-7-60 552308

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death