BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 3143151 · Received May 30, 2013

    Report

    Report Number
    3003793491-2013-00645
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    June 11, 2012
    Report Date
    July 25, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WILL NOT BE RETURNED TO ZOLL MEDICAL CORPORATION FOR ANALYSIS THEREFORE A SUPPLEMENTAL REPORT WILL NOT BE SUBMITTED. PRODUCT LABELING "INSTRUCTION FOR USE" STATES THAT: "POSSIBLE COMPLICATIONS WITH CENTRAL VENOUS CATHETERS INCLUDE: ATRIAL OR VENTRICULAR PERFORATION, CARDIAC TAMPONADE, AIR EMBOLISM, CATHETER EMBOLISM, THORACIC DUCT LACERATION, BACTEREMIA, SEPTICEMIA, THROMBOSIS, INADVERTENT ARTERIAL PUNCTURE, HEMATOMA FORMATION, HEMORRHAGE, NERVE DAMAGE AND DYSRHYTHMIAS". NOTE: FIRST PATIENT IS REPORTED UNDER MFR# 3003793491-2013-00644. SECOND PATIENT IS REPORTED UNDER MFR# 3003793491-2013-00645. THIRD PATIENT IS REPORTED UNDER MFR# 3003793491-2013-00646. FOURTH AND FIFTH PATIENT ARE REPORTED UNDER MFR# 3003793491-2013-00647.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT THEY HAVE HAD 4 AND POSSIBLY A 5TH PATIENT TREATED WITH ZOLL CIRCULATION COOLING CATHETERS RESULT IN DVT (DEEP VEIN THROMBOSIS) IN (B)(6). THREE OF THESE WERE ICU PATIENTS, OF THIS ONE WITH TRAUMATIC BRAIN INJURY AND ONE WAS A POST CARDIAC ARREST PATIENT. ADDITIONAL INFORMATION WAS RECEIVED WHERE IT WAS INDICATED THAT A (B)(6) MALE WAS ADMITTED WITH MULTIPLE TRAUMA AFTER A MOTOCROSS ACCIDENT. INJURIES SUSTAINED BY THE PATIENT INCLUDED (TBI) TRAUMATIC BRAIN INJURY, LEFT PNEUMOTHORAX, RIGHT PULMONARY CONTUSION, RIGHT SHOULDER DISLOCATION. PATIENT DID NOT SUSTAIN ANY LOWER EXTREMITY OR PELVIC FRACTURES. NORMOTHERMIA WAS INDUCED FOR TREATMENT OF FEVER IN A PATIENT WITH SEVERE TBI. SEQUENCE OF EVENTS ARE FOLLOWS: ON (B)(6) 2012 A COOL LINE CATHETER WAS INSERTED INTO THE RIGHT FEMORAL VEIN. ON (B)(6) 2012 THE COOL LINE CATHETER WAS REMOVED FROM THE RIGHT FEMORAL VEIN AS IT WAS NO LONGER REQUIRED. ON (B)(6) 2012 AN ABDOMINAL ULTRASOUND WAS PERFORMED TO EVALUATE ABNORMAL LIVER TESTS AND AN INCIDENTAL FINDING SHOWED A 1.1 X 0.8 CM THROMBUS IN RETRO-HEPATIC IVC (INFERIOR VENA CAVAGRAM). THE INFERIOR VENA CAVAGRAM SHOWED THE PRESENCE OF A NON-OCCLUSIVE THROMBUS EXTENDING FROM THE SUPRA-RENAL PORTION OF THE IVC TO THE INTRA-HEPATIC PORTION OF THE IVC. NORMAL INFLOW FROM THE RENAL VEINS WAS PRESENT. INFERIOR VENA CAVA (IVC) FILTER WAS PLACED IN THE SUPRA-RENAL IVC. ON (B)(6) 2012 AN ULTRASOUND WAS PERFORMED WHICH SHOWED DVT (DEEP VENOUS THROMBOSIS) IN THE RIGHT POSTERIOR TIBIAL AND PERONEAL VEINS, BUT NO PROXIMAL DVT WAS OBSERVED. ON (B)(6) 2012 A COMPUTERIZED TOMOGRAPHY (CT) CORONARY ANGIOGRAM WAS PERFORMED AND RESULTS SHOWED NO RESIDUAL THROMBUS. THE CATHETER WAS PLACED IN THE PATIENT FOR 159 HOURS. PHYSICIAN INDICATED THAT PATIENT WAS NOT AT HIGH RISK FOR DVT. ADDITIONAL INFORMATION WAS RECEIVED FROM ZOLL CLINICAL SPECIALIST AND REPORTEDLY THE CATHETER AND IVTM SYSTEM WAS APPROPRIATELY UTILIZED IN THIS CASE AND THERE WAS NO MISUSE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240125 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION, INC. CL-2295A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other SEDATION| MECHANICAL VENTILATION| ICP MONITORING