BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN E

    MDR report key: 21044635 · Received December 30, 2024

    Report

    Report Number
    3010617000-2024-01042
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Report Date
    February 3, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075275
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE CATHETER IN COMPLAINT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF AND WHEN THE PRODUCT IS RETURNED, AND AN INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION B5 WAS CORRECTED WITH THE UPDATED LOT NUMBER. THE REPORTED COMPLAINT OF DIFFICULTY IN ADVANCING THE QUATTRO CATHETER WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS DUE TO THE KINKED GUIDEWIRE, LIKELY ATTRIBUTED TO AN ISSUE OF INSERTION OR REMOVAL OF THE GUIDEWIRE. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. THE CATHETER WAS RETURNED WITH THE GUIDEWIRE STUCK INSIDE THE CATHETER, CONFIRMING THE REPORTED COMPLAINT. FUNCTIONAL TESTING WAS PERFORMED. THE GUIDEWIRE WAS STUCK INSIDE THE CATHETER AND WAS UNABLE TO BE REMOVED FROM THE PROXIMAL END OF THE DISTAL LUER PORT, HOWEVER, IN ORDER TO REMOVE THE GUIDEWIRE, IT HAD TO BE REMOVED BY PULLING IT OUT FROM THE CATHETER TIP. A KNOWN-GOOD ZOLL GUIDEWIRE WAS SLOWLY INSERTED INTO THE TIP OF THE CATHETER AND EXITED TO THE DISTAL LUER PORT WITHOUT RESISTANCE. THE GUIDEWIRE COULD BE PASSED THROUGH THE ENTIRE LENGTH OF THE LUMEN WITH NO RESISTANCE. HISTORICAL COMPLAINTS WERE REVIEWED FOR INVESTIGATION RESULT RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE QUATTRO CATHETER WITH LOT NUMBER 198225.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE WITH ADVANCING THE QUATTRO CATHETER (LOT # 200089) AND RETRACTING THE GUIDEWIRE DURING CATHETER INSERTION INTO A PATIENT'S FEMORAL VEIN. THE GUIDEWIRE BECAME STUCK AND COULD NOT BE REMOVED, SO BOTH THE CATHETER AND GUIDEWIRE WERE TAKEN OUT TOGETHER WITHOUT ANY SURGICAL INTERVENTION OR ISSUES. A NEW GUIDEWIRE WAS USED TO INSERT A REPLACEMENT CATHETER AT THE SAME INSERTION SITE. THIS INCIDENT OCCURRED IN THE PAST AND WAS NOT REPORTED TO ZOLL AT THE TIME. UNFORTUNATELY, THE ATTENDING PHYSICIAN NO LONGER RECALLS WHICH PATIENT IT WAS, ONLY THAT THE PATIENT HAD DIED FROM ANOTHER CAUSE. THE CUSTOMER SUSPECTS THAT THERE WAS A TIGHTER BEND IN THE VESSEL, WHICH MADE IT SOMEWHAT MORE DIFFICULT TO ADVANCE THE CATHETER AND REMOVE THE GUIDEWIRE. NO PATIENT INJURY RELATED TO THE ZOLL DEVICE WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE WITH ADVANCING THE QUATTRO CATHETER (LOT # 198225) AND RETRACTING THE GUIDEWIRE DURING CATHETER INSERTION INTO A PATIENT'S FEMORAL VEIN. THE GUIDEWIRE BECAME STUCK AND COULD NOT BE REMOVED, SO BOTH THE CATHETER AND GUIDEWIRE WERE TAKEN OUT TOGETHER WITHOUT ANY SURGICAL INTERVENTION OR ISSUES. A NEW GUIDEWIRE WAS USED TO INSERT A REPLACEMENT CATHETER AT THE SAME INSERTION SITE. THIS INCIDENT OCCURRED IN THE PAST AND WAS NOT REPORTED TO ZOLL AT THE TIME. UNFORTUNATELY, THE ATTENDING PHYSICIAN NO LONGER RECALLS WHICH PATIENT IT WAS, ONLY THAT THE PATIENT HAD DIED FROM ANOTHER CAUSE. THE CUSTOMER SUSPECTS THAT THERE WAS A TIGHTER BEND IN THE VESSEL, WHICH MADE IT SOMEWHAT MORE DIFFICULT TO ADVANCE THE CATHETER AND REMOVE THE GUIDEWIRE. NO PATIENT INJURY RELATED TO THE ZOLL DEVICE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847454 QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN E INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-4593AE 198225 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown