BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 9227311 · Received October 23, 2019

    Report

    Report Number
    3010617000-2019-01007
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    September 28, 2019
    Report Date
    January 13, 2020
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A LEAKING QUATTRO CATHETER (LOT# 92473) WAS CONFIRMED DURING FUNCTIONAL TESTING. A PINHOLE LEAK THE DISTAL END OF DISTAL BALLOON. THE INVESTIGATION FINDINGS REVEALED THAT THE PROBABLE CAUSE OF THE REPORTED COMPLAINT WAS DUE TO A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED QUATTRO CATHETER WAS PERFORMED. THE BALLOONS WERE EXAMINED AND THERE WERE NO TEARS, BALLOON BOND DETACHMENT OR RUPTURE NOTED. DRIED BLOOD WAS OBSERVED ON THE LUERS TUBINGS AND BALLOONS. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE AND IMMEDIATELY A PINHOLE LEAK THE DISTAL END OF DISTAL BALLOON. THUS, CONFIRMING THE REPORTED COMPLAINT. DURING MANUFACTURING ALL CATHETERS ARE 100% INSPECTED FOR LEAKS BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR A CATHETER WITH LOT NUMBER 92473. PER ZOLL MEDICAL SAFETY ASSESSMENT, THE PATIENT WAS ADMITTED AFTER CARDIAC ARREST. HYPOTHERMIA AFTER CARDIAC ARREST (HACA) WAS COMPLETED. CATH LAB INSERTED QUATTRO CATHETER VIA RIGHT FEMORAL VEIN FOR IVTM TREATMENT. DURING INITIATION OF THE IVTM TREATMENT, RN OBSERVED BLOOD BACKING UP ON THE START-UP KIT (SUK). FOLLOWING THIS, QUATTRO CATHETER WAS REMOVED AND USER OBSERVED A BALLOON BREACH. THE LINE WAS CHANGED OUT AND HACA WAS COMPLETED VIA A NEW LINE. PATIENT PASSED AFTER TWO DAYS DUE TO ANOXIC BRAIN INJURY, DEATH REPORTED AS UNRELATED TO THE QUATTRO CATHETER. EVENT OF DEATH WAS SERIOUS BECAUSE IT MET CRITERIA FOR SERIOUSNESS (DEATH). THE PATIENT WAS IN A CRITICAL CONDITION AFTER CARDIAC ARREST. DEATH DUE TO ANOXIC BRAIN INJURY WAS PROBABLY DUE TO THE PATIENT'S CLINICAL CONDITION.

    Additional Manufacturer Narrative · 0

    CORRECTED B5. RECEIVED MEDWATCH REPORT MW5090286 ON 18 OCT 2019. THE PATIENT WAS ADMITTED AFTER CARDIAC ARREST. HYPOTHERMIA AFTER CARDIAC ARREST (HACA) WAS COMPLETED. CATH LAB INSERTED QUATTRO CATHETER VIA RIGHT FEMORAL VEIN FOR IVTM TREATMENT. DURING INITIATION OF THE IVTM TREATMENT, RN OBSERVED BLOOD BACKING UP ON THE START-UP KIT (SUK). FOLLOWING THIS, QUATTRO CATHETER WAS REMOVED AND USER OBSERVED A BALLOON BREACH. THE LINE WAS CHANGED OUT AND HACA WAS COMPLETED VIA A NEW LINE. PATIENT PASSED AFTER TWO DAYS DUE TO ANOXIC BRAIN INJURY, DEATH REPORTED AS UNRELATED TO THE QUATTRO CATHETER. EVENT OF DEATH WAS SERIOUS BECAUSE IT MET CRITERIA FOR SERIOUSNESS (DEATH). THE PATIENT WAS IN A CRITICAL CONDITION AFTER CARDIAC ARREST. DEATH DUE TO ANOXIC BRAIN INJURY WAS PROBABLY DUE TO THE PATIENT'S CLINICAL CONDITION.

    Description of Event or Problem · 0

    REGISTERED NURSE (RN) RECEIVED PATIENT FROM THE CATH LAB WITH ARTERIAL AND VENOUS SHEATHS AND QUATTRO CATHETER (LOT# 88638) IN THE RIGHT FEMORAL VEIN. DURING INITIATION OF THE IVTM TREATMENT, RN OBSERVED BLOOD BACKING UP ON THE START-UP KIT (SUK). FOLLOWING THIS, QUATTRO CATHETER WAS REMOVED AND USER OBSERVED A BALLOON BREACH. UPON REPLACING THE CATHETER, HYPOTHERMIA AFTER CARDIAC ARREST (HACA) WAS COMPLETED. PATIENT PASSED AFTER TWO DAYS DUE TO ANOXIC BRAIN INJURY, DEATH WAS UNRELATED TO THE CATHETER EVENT.

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. ONLY LIMITED INFORMATION IS AVAILABLE. THE PATIENT WAS ADMITTED AFTER CARDIAC ARREST. HYPOTHERMIA AFTER CARDIAC ARREST (HACA) WAS COMPLETED. CATH LAB INSERTED QUATTRO CATHETER VIA FEMORAL VEIN FOR IVTM TREATMENT. AT UNSPECIFIED TIME, QUATTRO CATHETER WAS REMOVED AND USER OBSERVED A BALLOON BREACH. THE LINE WAS CHANGED OUT AND HACA WAS COMPLETED VIA A NEW LINE. PATIENT PASSED, DEATH REPORTED AS UNRELATED TO THE QUATTRO CATHETER. EVENT OF DEATH WAS SERIOUS BECAUSE IT MET CRITERIA FOR SERIOUSNESS (DEATH). THE PATIENT WAS IN A CRITICAL CONDITION AFTER CARDIAC ARREST. DEATH IS PROBABLY DUE TO THE PATIENT'S CLINICAL CONDITION.

    Description of Event or Problem · 1

    DURING UNSPECIFIED TIME OF IVTM TREATMENT, QUATTRO CATHETER WAS REMOVED AND USER OBSERVED A BALLOON BREACH. UPON REPLACING THE CATHETER, HYPOTHERMIA AFTER CARDIAC ARREST (HACA) WAS COMPLETED. PATIENT PASSED DUE TO ANOXIC BRAIN INJURY, DEATH WAS UNRELATED TO THE CATHETER EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020459 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION 8700-0783-01 92473

    Patients

    Seq Age Sex Outcome Treatment
    1