BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 3170393 · Received June 7, 2013

    Report

    Report Number
    3003793491-2013-00672
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN COMPLAINT WILL NOT BE RETURNED TO ZOLL CIRCULATION FOR PHYSICAL INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER (PHYSICIAN) REPORTED THAT DURING A ROUTINE ECHO PER HOSPITAL THERAPEUTIC HYPOTHERMIA (TH) PROTOCOL, THROMBUS WAS NOTED IN THE INFERIOR VENA CAVA (IVC). A (B)(6) MALE, WEIGHING (B)(6), WAS HOSPITALIZED ON (B)(6) 2013. THE PT HAD EXPERIENCED CARDIAC ARREST WITH ROSC AND WAS HOSPITALIZED FOR TH. THE IVTM QUATTRO CATHETER WAS INSERTED IN THE RIGHT FEMORAL VEIN BY A PHYSICIAN WHO HAS USED ZOLL DEVICES IN APPROX 12 CASES. REPORTEDLY, THE CATHETER WAS INSERTED SMOOTHLY IN ONE ATTEMPT AND WAS KEPT IN THE PT FOR APPROX 72 HOURS AS PER HOSPITAL PROTOCOL. THERE WERE NO OTHER TEMPERATURE MANAGEMENT PROCEDURES PERFORMED. AT THE START OF IVTM THERAPY, THE PT'S TEMPERATURE WAS APPROX 35 DEGREE TO 36 DEGREE CELSIUS. THE TARGET TEMPERATURE WAS AT 33 DEGREE CELSIUS AND THE ISSUE WAS NOTED AT 36.5 DEGREE CELSIUS (NORMOTHERMIA). THE RATE OF WARMING WAS SET AT 0.25 DEGREE CELSIUS/HR. THE SYSTEM HAD BEEN RUNNING IN WARMING MODE FOR APPROX 16 HOURS. THERE WERE NO SYSTEM ALARMS NOTICED DURING TREATMENT. DURING THE ROUTINE ECHO, A 1.3 BY 1.0 CM AND 3.0 BY 0.9 CM THROMBUS WAS NOTED IN THE DISTAL INFERIOR VENA CAVA. BLOOD COAGULOPATHY RESULTS WERE NOT AVAILABLE PRIOR TO INITIATION OF THE IVTM THERAPY. THE PT WAS ON S/C UNFRACTIONATED HEPARIN AND IV HEPARIN. REPORTEDLY, THE PT WAS IN A HIGH RISK CATEGORY FOR DVT (TYPE NOT INDICATED). THE PT DID NOT HAVE A CENTRAL VENOUS CATHETER (CVC) PLACEMENT PRIOR TO ZOLL CATHETER. THERE WAS NO PLANNED INTERVENTION REPORTED. AS OF (B)(6) 2013, THE PT IS STILL HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253624 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION, INC IC-4593 37479

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R IV HEPARIN| S/C UNFRACTIONATED HEPARIN