BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX CATHETER

    MDR report key: 10997835 · Received December 13, 2020

    Report

    Report Number
    3010617000-2020-01247
    Event Type
    Malfunction
    Date Received
    December 13, 2020
    Date of Event
    November 18, 2020
    Report Date
    December 11, 2020
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075305
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF THE SOLEX CATHETER (LOT # 142616) WAS DIFFICULT TO REMOVE IS CONFIRMED. AS REPORTED IN THE COMPLAINT, THE CATHETER WAS CUT 1CM AWAY FROM THE MANIFOLD AND TWO LOOPS HAD TORN AWAY FROM THE SHAFT. THE CATHETER SHAFT WAS KINKED IN THE MIDDLE OF THE BALLOON, WHICH IS CONSISTENT WITH THE REPORTED DIFFICULTY IN FLUSHING THE PROXIMAL AND MEDIAL LUMENS SOON AFTER THE PLACEMENT. BASED ON THE AVAILABLE INFORMATION, IT IS MOST LIKELY THAT THE CATHETER WAS KINKED DUE TO HANDLING DURING INSERTION, WHICH MAY HAVE MADE THE REMOVAL OF CATHETER DIFFICULT. ATTEMPTS TO REMOVE AGAINST THE RESISTANCE IS THE MOST LIKELY ROOT CAUSE OF THE TORN BALLOONS. NO BALLOON MATERIAL SEEMS TO BE MISSING. THE RETURNED CATHETER COULD NOT BE TESTED DUE TO THE CONDITION IT WAS RECEIVED IN. THERE WAS NO HARM TO THE PATIENT AS VERIFIED BY THE CT SCAN. THE ROOT CAUSE OF THIS COMPLAINT IS MISHANDLING DURING INSERTION. DURING VISUAL INSPECTION, THE SOLEX CATHETER WAS RETURNED COMPLETELY DAMAGED. THE CATHETER SHAFT WAS CUT AT 1 CM. AWAY FROM THE DISTAL END OF THE MANIFOLD. THE CATHETER SHAFT WAS KINKED AT THE MIDDLE OF THE SERPENTINE BALLOON (6 CM. AWAY FROM THE TIP OF THE CATHETER). THE SERPENTINE BALLOON WAS COMPLETELY DAMAGED (THE TWO LOOPS WERE DETACHED FROM THE CATHETER). BLOOD WAS OBSERVED ON THE CATHETER BALLOON. IT IS UNLIKELY THAT SUCH A DEFECTIVE CATHETER WAS SHIPPED. DURING MANUFACTURING ALL SOLEX CATHETERS ARE 100% INSPECTED. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO SIMILAR COMPLAINT REPORTED FOR SOLEX 7 CATHETER WITH LOT NUMBER 142616.

    Description of Event or Problem · 1

    AS REPORTED, THE USER HAD DIFFICULTY IN REMOVING THE SOLEX CATHETER (LOT # 142616) OFF THE PATIENT. DURING REMOVAL THE PHYSICIAN EXPERIENCE RESISTANCE, IT WAS OBSERVED THAT THE BALLOON OF THE CATHETER WAS TEARING OFF. THE PHYSICIAN CUT THE CATHETER FROM WHERE THE BALLOON STARTS DUE TO THE CONCERN OF THE SALINE WAS NOT DRAINING OUT OF THE ORANGE LUER. AFTER SUCCESSFULLY REMOVING THE CATHETER, THE PATIENT WAS SENT TO CT TO CONFIRM THAT THERE WERE NO DAMAGE TO THE PATIENT AND PRELIMINARY REPORT STATED THAT NO HARM DONE TO THE PATIENT. IN ADDITION, THE NURSE STATED THAT AFTER THE CATHER WAS PLACED INTO THE PATIENT, THEY WERE UNABLE TO FLUSH BOTH THE PROXIMAL AND MEDIAL PORT OF THE SOLEX CATHETER, AND USED THE DISTAL PORT FOR VASOPRESSORS. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463919 ZOLL IVTM SOLEX CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593 142616 00849111075305

    Patients

    Seq Age Sex Outcome Treatment
    1