MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM QUATTRO CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-4593
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After 40 hours of ivtm therapy for a patient with cardiopulmonary arrest, the therapy was paused and the start-up kit (suk) (lot #158572) was disconnected from the catheter for the patient examination and connected back 30 minutes later to continue the therapy.Per the reporter, the pinwheel was spinning after the catheter was reconnected to the suk and no kinks or obstructions to the suk tubing were noted.The customer observed bleeding from the catheter insertion site.The pressure was applied to mitigate the bleeding.Twenty minutes after the therapy restarted the user heard a bursting noise and the lfl tube portion of the suk just after the rotor pump was observed swollen and torn with saline leaking externally.The thermogard console generated the air trap alarm and the therapy was stopped.The customer verified that the catheter was secure and in the correct depth position.The customer suspected the catheter leak.The catheter was removed from the patient, however, after performing a balloon leak test on the catheter, the saline leak was not confirmed.The treatment was continued using the alternative temperature management device (blanket roll).The customer did not provide the reason for not continuing the ivtm therapy, however, the console was confirmed to be functional.No consequences or impact to the patient.In addition, the customer reported the bubbles in the suk and water droplets formation inside the lid of the roller pump after the second day of the treatment.
Additional Manufacturer Narrative
The zoll icy catheter was not returned to zoll for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.Event of bleeding was not serious, the patient did not require treatment, and event resolved without sequelae.Event was probably related to the zoll catheter due to relevant timing and location at insertion site.Bleeding at insertion site is anticipated event and could potentially occur with usage of any catheter.
Additional Manufacturer Narrative
The functional testing of the returned quattro catheter (lot # 155959) was performed and there was no device malfunction observed.The catheter worked as intended.A visual examination of the returned catheter was performed and found no physical damage to the catheter.A functional pressure leak test of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.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.Event of bleeding was not serious, the patient did not require treatment, and event resolved without sequelae.Event was probably related to the zoll catheter due to relevant timing and location at insertion site.Bleeding at insertion site is anticipated event and could potentially occur with usage of any catheter.The event is probably related to the device and is not related to the procedure.Additional information, correction, b5: (describe event or problem) was updated based on the received quattro catheter lot # 155959.
Event or Problem Description
After 40 hours of ivtm therapy for a patient with cardiopulmonary arrest, the therapy was paused and the start-up kit (suk) (lot # 158572) was disconnected from the quattro catheter (lot # 155959) for the patient examination and connected back 30 minutes later to continue the therapy.Per the reporter, the pinwheel was spinning after the catheter was reconnected to the suk and no kinks or obstructions to the suk tubing were noted.The customer observed bleeding from the catheter insertion site.The pressure was applied to mitigate the bleeding.Twenty minutes after the therapy restarted the user heard a bursting noise and the lfl tube portion of the suk just after the rotor pump was observed swollen and torn with saline leaking externally.The thermogard console generated the air trap alarm and the therapy was stopped.The customer verified that the catheter was secure and in the correct depth position.The customer suspected the catheter leak.The catheter was removed from the patient, however, after performing a balloon leak test on the catheter, the saline leak was not confirmed.The treatment was continued using the alternative temperature management device (blanket roll).The customer did not provide the reason for not continuing the ivtm therapy, however, the console was confirmed to be functional.In addition, the customer reported the bubbles in the suk and water droplets formation inside the lid of the roller pump after the second day of the treatment.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13764708
• Report Number: 3010617000-2022-00266
• Device Sequence Number: 20082021
• Product Code: NCX
• UDI-Device Identifier: 00849111075527
• UDI-Public: 00849111075527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IC-4593
• Device Catalogue Number: 8700-0783-03
• Device Lot Number: 155959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown