BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 5043672 · Received August 31, 2015

    Report

    Report Number
    3010617000-2015-00480
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 6, 2015
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075138
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTS OF A DEVICE DEFICIENCY. ADDITIONALLY, THE ZOLL CATHETER WAS LEFT IN THE PATIENT FOR A LONGER PERIOD (6 DAYS) THAN IS RECOMMENDED. PER THE INSTRUCTIONS FOR USE (IFU), THE IN-DWELL TIME FOR THE ZOLL QUATTRO CATHETER IS 4 DAYS, WHICH WAS EXCEEDED. PER ZOLL LABELING, POSSIBLE COMPLICATIONS WITH CENTRAL VENOUS CATHETERS INCLUDE THROMBOSIS. ADDITIONALLY, CATHETER RELATED THROMBOSIS ARE KNOWN COMPLICATIONS WITH INTRAVASCULAR CATHETER USE OF ANY KIND. IT SHOULD ALSO BE NOTED THAT THE PATIENT WAS CONSIDERED IN A HIGH RISK CATEGORY FOR DVT. THE ZOLL CATHETER USED DURING THE EVENT WILL NOT BE RETURNED FOR INVESTIGATION. THEREFORE, A PHYSICAL INVESTIGATION WILL NOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A MALE PATIENT WEIGHING (B)(6) WAS HOSPITALIZED FOR A TRAUMATIC BRAIN INJURY (TBI). THERE WERE NO CONDITIONS CAUSING THE PATIENT TO BE NON-AMBULATORY PRIOR TO HOSPITALIZATION. THE HOSPITAL STAFF WAS UNWILLING TO PROVIDE THE PATIENT'S AGE AND MEDICAL HISTORY. IT IS UNKNOWN WHAT MEDICATIONS THE PATIENT WAS TAKING. THE REASON FOR THERAPEUTIC IVTM WAS FOR NORMOTHERMIA. PATIENT'S TEMPERATURE PRIOR TO IVTM THERAPY IS UNKNOWN. THERE WERE NO ADJUNCTIVE TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED ON THE PATIENT. THE HOSPITAL WAS UNWILLING TO PROVIDE INFORMATION ON WHETHER THERE WERE OTHER INTERVENTIONS OR PROCEDURES PERFORMED ON THE PATIENT TO ADDRESS THE CAUSE OF HOSPITALIZATION AND RELATED HEALTH ISSUES. BLOOD COAGULOPATHY RESULTS PRIOR TO INITIATION OF THERAPY ARE NOT AVAILABLE. THERE WAS NO SEPARATE CATHETER USED FOR THE CENTRAL LINE. PATIENT WAS SYSTEMATICALLY ANTI-COAGULATED WITH SUBCUTANEOUS HEPARIN. THE ZOLL CONSOLE WAS SET TO MAX MODE. THE DESIRED TARGET TEMPERATURE FOR THE PATIENT WAS 37 DEGREES CELSIUS. THE ACTUAL SET POINT ON THE CONSOLE WAS ALSO 37 DEGREES CELSIUS. IT IS UNKNOWN WHAT THE ROOM TEMPERATURE WAS. A FOLEY (MANUFACTURED BY BARD) URINARY TEMPERATURE PROBE WAS PLACED. A ZOLL QUATTRO CATHETER WAS SUCCESSFULLY PLACED INTO THE RIGHT FEMORAL VEIN ON (B)(6) 2015. CATHETER INSERTION WAS MADE IN ONE ATTEMPT. IT IS UNKNOWN IF INSERTION WAS DIFFICULT OR SMOOTH. IT IS ALSO UNKNOWN WHAT LEVEL OF EXPERIENCE THE PHYSICIAN HAS WITH INTRAVASCULAR CATHETER PLACEMENT. CUSTOMER REPORTED THAT A DEEP VEIN THROMBOSIS (DVT) WAS DISCOVERED VIA ULTRASOUND. THE CLOT FORMATION WAS LOCATED IN THE FEMORAL VEIN. THE DWELL TIME OF THE ZOLL CATHETER AT THE TIME THE DVT WAS DISCOVERED AND AT THE TIME OF CATHETER REMOVAL WAS 6 DAYS. THERE WERE NO VESSEL INJURIES CAUSED BY THE ZOLL CATHETER. THE DVT WAS MITIGATED BY AN INFERIOR VENA CAVA (IVC) FILTER. IT IS UNKNOWN IF MEDICATIONS WERE GIVEN TO THE PATIENT. PATIENT IS CURRENTLY ALIVE. PER THE NURSE MANAGER, THE PATIENT WAS IN A HIGH RISK CATEGORY FOR DVT. THE NURSE MANAGER ALSO SUGGESTED THAT THE ZOLL CATHETER WAS THE ONLY CATHETER IN THE PATIENT THAT WOULD BE ATTRIBUTABLE TO THE DVT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575319 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION 8700-0660-01 UNKNOWN 00849111075138

    Patients

    Seq Age Sex Outcome Treatment
    1 Other