BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 11219967 · Received January 23, 2021

    Report

    Report Number
    3010617000-2021-00050
    Event Type
    Malfunction
    Date Received
    January 23, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 29, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075282
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT ABOUT THE QUATTRO CATHETER (LOT # 141936) LEAK WAS CONFIRMED. DURING THE FUNCTIONAL LEAK TEST, A PINHOLE LEAK WAS OBSERVED FROM THE MIDDLE OF THE DISTAL BALLOON. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS DUE TO A LATENT MATERIAL DEFECT. A VISUAL EXAMINATION OF THE RETURNED CATHETER WAS PERFORMED AND FOUND NO PHYSICAL DAMAGE TO THE CATHETER. DRIED BLOOD RESIDUE WAS OBSERVED IN THE BALLOONS AND IN THE LUERED TUBINGS. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED, EXCEPT MEDIAL AND IN/OUT LUERED PORTS DUE TO CLOGGED BLOOD. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE FOR ONE MINUTE, THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. IMMEDIATELY UPON PRESSURIZING THE CATHETER, A PINHOLE LEAK WAS OBSERVED IN THE MIDDLE OF THE DISTAL BALLOON. THUS, CONFIRMING THE CUSTOMER 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 SIMILAR COMPLAINT REPORTED FOR THE QUATTRO CATHETER WITH LOT # 141936. ADDITIONAL INFORMATION: B5, (DESCRIBE EVENT OR PROBLEM) WAS UPDATED BASED ON THE RECEIVED QUATTRO CATHETER LOT # 141936. CORRECTION: H6, HEALTH EFFECT - CLINICAL CODE AND IMPACT CODE, D4, LOT # WAS UPDATED.

    Description of Event or Problem · 0

    DURING THE IVTM THERAPY, THE NURSE NOTICED BLOOD BACKING UP INTO THE START-UP KIT (SUK) TUBING. THE QUATTRO CATHETER (LOT# 141936) LEAK WAS SUSPECTED. THE NURSE WAS NOTIFIED TO STOP THE TREATMENT AND WARN THE PRIMARY PHYSICIAN THAT THE QUATTRO CATHETER NEEDS TO BE REPLACED. THE CATHETER ISSUE WAS OBSERVED WHEN THE PATIENT WAS IN THE INTERVENTIONAL RADIOLOGY (IR) FOR THE STENT PLACEMENT. PER THE REPORTER, THE PHYSICIAN WANTS TO CONTINUE THE USE OF THE QUATTRO CATHETER AS A CENTRAL LINE TO DELIVER MEDICATION FOR THE BLOOD PRESSURE SUPPORT. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE, THEREFORE THE PATIENT'S STATUS IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS COMPLAINT HAS NOT YET RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE CATHETER IS RETURNED AND THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING THE IVTM THERAPY, THE NURSE NOTICED BLOOD BACKING UP INTO THE START-UP KIT (SUK) TUBING. THE QUATTRO CATHETER (LOT# UNKNOWN) LEAK WAS SUSPECTED. THE NURSE WAS NOTIFIED TO STOP THE TREATMENT AND WARN THE PRIMARY PHYSICIAN THAT THE QUATTRO CATHETER NEEDS TO BE REPLACED. THE CATHETER ISSUE WAS OBSERVED WHEN THE PATIENT WAS IN THE INTERVENTIONAL RADIOLOGY (IR) FOR THE STENT PLACEMENT. PER THE REPORTER, THE PHYSICIAN WANTS TO CONTINUE THE USE OF THE QUATTRO CATHETER AS A CENTRAL LINE TO DELIVER MEDICATION FOR THE BLOOD PRESSURE SUPPORT. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE, THEREFORE THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116446 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 141936 00849111075282

    Patients

    Seq Age Sex Outcome Treatment
    1