BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE

    MDR report key: 21044636 · Received December 30, 2024

    Report

    Report Number
    3010617000-2024-01043
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Report Date
    February 3, 2025
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    DQX
    UDI-DI
    00886333211753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K): PREMARKET SUBMISSION NUMBER NOT AVAILABLE/NOT RELEASED. ZOLL HAS NOT RECEIVED THE GUIDEWIRE 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. SECTIONS D2, D9, AND H4 WERE UPDATED. THE REPORTED COMPLAINT OF AN ISSUE WITH RETRACTING THE GUIDEWIRE WAS CONFIRMED. THE GUIDEWIRE WAS RETURNED STUCK INSIDE THE CATHETER AND WAS COMPLETELY DAMAGED, WITH SEVERAL KINKS AND BENDS OBSERVED ALONG ITS LENGTH. THE PROBABLE ROOT CAUSE COULD BE RELATED TO THE INSERTION OR REMOVAL PROCESS OF THE GUIDEWIRE. DURING THE VISUAL INSPECTION OF THE RETURNED GUIDEWIRE, IT WAS FOUND STUCK INSIDE THE CATHETER AND COULD NOT BE REMOVED FROM THE PROXIMAL END OF THE DISTAL LUER PORT. TO REMOVE THE GUIDEWIRE, IT HAD TO BE PULLED OUT FROM THE CATHETER TIP. THE GUIDEWIRE WAS COMPLETELY DAMAGED, WITH KINKS AND BENDS LOCATED AT 10 INCHES, 8 INCHES FROM THE J HOOK, AND AT THE DISTAL END OF THE J HOOK. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION IN WHICH THE GUIDEWIRE WAS RECEIVED. HISTORICAL COMPLAINTS WERE REVIEWED FOR INVESTIGATION RESULT RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE GUIDEWIRE 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
    1847455 GUIDEWIRE CARDIAC/PERIPHERAL VASCULAR GUIDEWIRE, SINGLE-USE DQX ARGON MEDICAL DEVICES, INC. 395613 198225 00886333211753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown