BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 15366607 · Received September 6, 2022

    Report

    Report Number
    3010617000-2022-01489
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 5, 2022
    Report Date
    February 6, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075237
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED A COMPLAINT THAT "THE ICY CATHETER (LOT # 170780) COULD NOT BE ADVANCED OVER THE GUIDEWIRE AND THE GUIDEWIRE GOT STUCK WITHIN THE ICY CATHETER AND COULD NOT BE RETRIEVED," WAS CONFIRMED DURING THE VISUAL INSPECTION PERFORMED AT ZOLL. THE DEVICE WAS RETURNED WITH THE GUIDEWIRE STUCK INSIDE THE CATHETER. THE GUIDEWIRE WAS COMPLETELY DAMAGED AND COULD NOT BE REMOVED FROM THE CATHETER. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, USER HANDLING COULD NOT BE RULED OUT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO OTHER PHYSICAL DAMAGE WAS FOUND ON THE CATHETER; OBSERVED BLOOD RESIDUES ON THE BALLOONS AND LUER TUBINGS. A FUNCTIONAL PRESSURE LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE, EXCEPT THE DISTAL LUER DUE TO THE STUCK GUIDEWIRE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI, AND NO ISSUES WERE OBSERVED. THE BALLOONS DID NOT LEAK DURING INFLATION AND DEFLATION. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND NO SIMILAR COMPLAINT WAS REPORTED FOR ICY CATHETER WITH LOT #170780. EVENT OF BLEEDING WAS SERIOUS; THE PATIENT DID REQUIRE TREATMENT - PRESSURE DRESSING PLACED FOLLOWED BY A WEIGHTED BAG AND FEMSTOP DEVICE TO PREVENT COMPLICATIONS; EVENT RESOLVED WITHOUT SEQUELAE. EVENT WAS PROBABLY RELATED TO THE ICY CATHETER DUE TO RELEVANT TIMING AND LOCATION AT THE TIME ON INSERTION. EVENT IS PROBABLY RELATED TO DEVICE DEFICIENCY. BLEEDING AT IV INSERTION SITE IS AN ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH USAGE OF ANY CATHETER. THE EVENT OF "BLEEDING AT INSERTION SITE" WAS PROBABLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    EVENT OF BLEEDING WAS SERIOUS; THE PATIENT DID REQUIRE TREATMENT - PRESSURE DRESSING PLACED FOLLOWED BY A WEIGHTED BAG AND FEMSTOP DEVICE TO PREVENT COMPLICATIONS; EVENT RESOLVED WITHOUT SEQUELAE. EVENT WAS PROBABLY RELATED TO THE ICY CATHETER DUE TO RELEVANT TIMING AND LOCATION AT THE TIME ON INSERTION. EVENT IS PROBABLY RELATED TO DEVICE DEFICIENCY AS ADDITIONAL REQUIRED MANIPULATIONS COULD CONTRIBUTE TO DEVELOPMENT OF BLEEDING AT INSERTION SITE. BLEEDING AT IV INSERTION SITE IS AN ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH USAGE OF ANY CATHETER. THE EVENT OF "BLEEDING AT INSERTION SITE" WAS PROBABLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INVESTIGATION WAS PERFORMED ON THE RETURNED CATHETER. THE DISTAL LUMEN WAS FLUSHED AGAIN, AND AFTER FLUSHING, THE STUCK GUIDEWIRE WAS ABLE TO BE REMOVED WITHOUT ANY DIFFICULTY. AFTER REMOVING THE STUCK GUIDEWIRE, A KNOWN-GOOD GUIDEWIRE WAS SLOWLY INSERTED INTO THE TIP OF THE CATHETER, AND NO RESISTANCE WAS NOTED. THE GUIDEWIRE WAS ABLE TO BE INSERTED SMOOTHLY WITH NO ISSUES.

    Description of Event or Problem · 0

    THE PHYSICIAN REPORTED THAT THE RESIDENT'S INITIAL ATTEMPTS AT VENIPUNCTURE TO PLACE THE ICY CATHETER INTO THE RIGHT FEMORAL VEIN WERE UNSUCCESSFUL. THE PHYSICIAN TOOK OVER AND INITIATED THE CATHETER PLACEMENT PROCEDURE USING THE FIRST ICY CATHETER. THE PHYSICIAN HAS AN EXTENSIVE EXPERIENCE SINCE 2007 IN INTRAVASCULAR CATHETER PLACEMENT. THE LEFT INGUINAL REGION WAS THEN PREPPED AND DRAPED, AND THE PHYSICIAN COULD ACCESS THE LEFT FEMORAL VEIN IN A SINGLE ATTEMPT BUT COULD NOT ADVANCE THE GUIDEWIRE MORE THAN HALF ITS LENGTH. THE PHYSICIAN WAS ABLE TO PERFORM DILATION OVER THE GUIDEWIRE BUT COULD NOT ADVANCE THE CATHETER BY MORE THAN 50% OF ITS LENGTH. THE PHYSICIAN REMOVED THE GUIDEWIRE AND TRIED TO RE-THREAD IT, BUT THE GUIDEWIRE GOT STUCK WITHIN THE CATHETER AND COULD NOT BE REMOVED. THE PHYSICIAN DECIDED TO REMOVE THE FIRST CATHETER AND GUIDEWIRE OUT OF THE VESSEL WHILE APPLYING PRESSURE TO MINIMIZE BLEEDING. THE PHYSICIAN STATED THAT THE BLEEDING WAS SIGNIFICANT AS THE TRACT HAD BEEN DILATED OVER THE GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO PLACE THE SECOND CATHETER ON THE SAME VESSEL. THE PHYSICIAN REASSESSED THE VESSEL USING THE FINDER NEEDLE AND WAS ABLE TO PASS A SECOND GUIDEWIRE THROUGH THE FINDER NEEDLE. THE PHYSICIAN STATED THAT DILATION WAS NOT NEEDED GIVEN THE EXISTING TRACT THAT HAD BEEN CREATED. HOWEVER, ANOTHER ATTEMPT AT INSERTING THE SECOND CATHETER OVER THE GUIDEWIRE WAS UNSUCCESSFUL. THE GUIDEWIRE BECAME STUCK WITHIN THE CATHETER AGAIN AND COULD NOT BE RETRIEVED EITHER. A PRESSURE DRESSING WAS PLACED OVER THE LEFT INGUINAL ACCESS SITE, FOLLOWED BY A WEIGHTED BAG AND A "FEM-STOP DEVICE" TO STOP THE BLEEDING. THE PHYSICIAN ATTEMPTED TO PLACE THE THIRD CATHETER INTO THE RIGHT FEMORAL VEIN, WHICH WAS SUCCESSFUL, AND THE IVTM THERAPY WAS CONTINUED. NO OTHER ADVERSE EFFECTS WERE NOTED. THE ICY CATHETERS USED DURING THE REPORTED EVENT WERE LOT #167003, 170780, AND 172322. IT IS UNKNOWN WHICH CATHETER WAS USED FIRST DURING THE REPORTED EVENT. THE PHYSICIAN STATED THAT TWO OF THE THREE CATHETERS WERE LIKELY DEFECTIVE. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-01487 FOR THE ICY CATHETER LOT #167003, MFR 3010617000-2022-01488 FOR THE ICY CATHETER LOT #172322, MFR 3010617000-2022-01536 FOR THE GUIDEWIRE LOT #171390, MFR 3010617000-2022-01537 FOR THE GUIDEWIRE LOT #UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431236 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 170780 00849111075237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R