BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 14553809 · Received May 31, 2022

    Report

    Report Number
    3010617000-2022-00553
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    May 8, 2022
    Report Date
    July 29, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ICY CATHETER AND GUIDEWIRE ASSOCIATED WITH THIS COMPLAINT WERE DISCARDED BY THE CUSTOMER. SINCE NO DEVICE WAS RETURNED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    EVENT OF ECCHYMOSIS, WHICH IS DISCOLORATION OF THE SKIN DUE TO THE RUPTURE OF THE BLOOD VESSELS BELOW THE SURFACE OF THE SKIN, WAS NOT SERIOUS, THE PATIENT DID NOT REQUIRE TREATMENT, AND EVENT RESOLVED WITHOUT SEQUELAE. EVENT WAS PROBABLY RELATED TO THE ZOLL CATHETER INSERTION DIFFICULTIES DUE TO RELEVANT TIMING AND LOCATION AT INSERTION SITE. ECCHYMOSIS AT INSERTION SITE DUE TO INSERTION DIFFICULTIES IS ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH USAGE OF ANY CATHETER. EVENT WAS PROBABLY RELATED TO THE ZOLL CATHETER BUT NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    WHILE INSERTING THE ICY CATHETER (LOT # 172512) INTO THE PATIENT'S RIGHT FEMORAL VEIN, THE PHYSICIAN FELT RESISTANCE. AS REPORTED, BOTH THE CATHETER AND GUIDEWIRE WERE INSPECTED BEFORE INSERTION AND NO ISSUE WAS NOTED. AFTER PERFORMING 3 UNSUCCESSFUL INSERTION ATTEMPTS, THE PHYSICIAN REMOVED THE CATHETER AND OBSERVED THAT BOTH THE ICY CATHETER AND GUIDEWIRE WERE KINKED. THE CATHETER WAS KINKED CLOSE TO THE DISTAL BALLOON, AND THE GUIDEWIRE WAS KINKED AT ABOUT 5~10 CM AWAY FROM THE DISTAL END. THE PATIENT HAD NO TORTUOUS ANATOMY, AND THE PHYSICIAN IS HIGHLY EXPERIENCED IN INTRAVASCULAR CATHETER PLACEMENT. THE PHYSICIAN USED ANOTHER ICY CATHETER KIT, WHICH WAS SUCCESSFULLY INSERTED INTO THE PATIENT'S VEIN TO INITIATE THE IVTM TREATMENT. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

    Description of Event or Problem · 0

    WHILE INSERTING THE ICY CATHETER (LOT # 172512) INTO THE PATIENT'S RIGHT FEMORAL VEIN, THE PHYSICIAN FELT RESISTANCE. AS REPORTED, BOTH THE CATHETER AND GUIDEWIRE (LOT # UNKNOWN) WERE INSPECTED BEFORE INSERTION AND NO ISSUE WAS NOTED. AFTER PERFORMING 3 UNSUCCESSFUL INSERTION ATTEMPTS, THE PHYSICIAN REMOVED THE CATHETER AND OBSERVED THAT BOTH THE ICY CATHETER AND GUIDEWIRE WERE KINKED. THE CATHETER WAS KINKED CLOSE TO THE DISTAL BALLOON, AND THE GUIDEWIRE WAS KINKED AT ABOUT 5 TO 10 CM AWAY FROM THE DISTAL END. THE PATIENT HAD NO TORTUOUS ANATOMY, AND THE PHYSICIAN IS HIGHLY EXPERIENCED IN INTRAVASCULAR CATHETER PLACEMENT. THE PHYSICIAN USED ANOTHER ICY CATHETER KIT, WHICH WAS SUCCESSFULLY INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN TO INITIATE THE IVTM TREATMENT. AFTER FAILING TO INSERT THE FIRST ICY CATHETER INTO THE PATIENT'S RIGHT FEMORAL VEIN, THE STAFF CONTINUED TO COMPRESS THE INSERTION SITE FOR 10 -15 MINUTES, PER THE CUSTOMER'S STANDARD CLINICAL PROCEDURE. THE NEXT DAY, THE CUSTOMER FOUND A FEW SKIN ECCHYMOSES AROUND THE INSERTION SITE. AFTER A FEW DAYS, THE ECCHYMOSES RESOLVED ON THEIR OWN WITHOUT REQUIRING ANY INTERVENTION AND/OR MEDICATIONS. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2022-00935 FOR THE GUIDEWIRE (LOT # UNKNOWN)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601186 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 172512 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other