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

Model Number	IC-4593AE
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the catheter in complaint for investigation.A follow-up report will be submitted if and when the product is returned, and an investigation has been completed.
Event or Problem Description
A quattro catheter (lot # unknown) was inserted into the patient's left femoral vein for ivtm therapy.An arterial line was also placed in the left femoral vein.After the patient reached the target temperature, the arterial line was removed.The re-warming phase of the treatment began, and the target temperature was set to achieve normothermia.When the patient's body temperature was at 95.5 °f, the nurse took the patient for a non-contrast ct scan.The nurse stated that there was no issue with the treatment until they returned from the ct scan.After the nurse brought the patient back and re-connected the start-up kit (suk) to the catheter, she noted that the 500-ml saline bag had begun to run dry.The patient's body temperature was at 94.2 °f at this time.The nurse contacted zoll, and a catheter leak check was performed per the zoll's new ifu.The nurse did not report any "air trap" alarms displayed by the thermogard console.The zoll clinical field specialist (cfs) also stated that there was no alarm heard in the background during the phone conversation with the nurse.The cfs instructed the nurse to put the thermogard console in standby mode and disconnect the suk.There was no puddle of saline observed on the ground, around the roller pump or air trap of the thermogard console, and on the patient's bed.All the tubing connections were tight.The cfs further instructed the nurse to use a slip-fit luer syringe to flush the catheter "in" luer with saline.The saline came out pink, and blood-tinged saline was noted in the tubing.This is an indication of a catheter balloon leak.The nurse did not report/suspect how much saline might have had infused into the patient's bloodstream.The nurse was instructed to remove the catheter and disconnect the patient from the thermogard system.The patient's body temperature remained at 94.2 °f during the phone call.After the patient was disconnected from the thermogard system, warming blankets were used to warm the patient.The nurse did not report any device malfunction on the thermogard console.No consequences or impact to the patient.
Additional Manufacturer Narrative
The reported complaint that "the 500-ml saline bag was running empty" was confirmed during functional testing performed at zoll.A bonding leak was observed at the distal end of medial 1 and at the proximal end of medial 2 balloons of the returned catheter.The probable root cause of the bonding leak could be a latent defect in the bond.A visual examination of the returned quattro catheter was performed and found no physical damage to the catheter.Dried blood residue was observed in the catheter's balloons and inside the luered tubings.During functional testing, all infusion ports and extension tubes were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi.Upon pressurizing the catheter, a bonding leak was observed at the distal end of the medial 1 and at the proximal end of medial 2 balloons, confirming the reported complaint.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.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 previous history of complaints reported for the quattro catheter with lot number 167692.
Event or Problem Description
A quattro catheter (lot # 167692) was inserted into the patient's left femoral vein for ivtm therapy.An arterial line was also placed in the left femoral vein.After the patient reached the target temperature, the arterial line was removed.The re-warming phase of the treatment began, and the target temperature was set to achieve normothermia.When the patient's body temperature was at 95.5 °f, the nurse took the patient for a non-contrast ct scan.The nurse stated that there was no issue with the treatment until they returned from the ct scan.After the nurse brought the patient back and re-connected the start-up kit (suk) to the catheter, she noted that the 500-ml saline bag had begun to run dry.The patient's body temperature was at 94.2 °f at this time.The nurse contacted zoll, and a catheter leak check was performed per the zoll's new ifu.The nurse did not report any "air trap" alarms displayed by the thermogard console.The zoll clinical field specialist (cfs) also stated that there was no alarm heard in the background during the phone conversation with the nurse.The cfs instructed the nurse to put the thermogard console in standby mode and disconnect the suk.There was no puddle of saline observed on the ground, around the roller pump or air trap of the thermogard console, and on the patient's bed.All the tubing connections were tight.The cfs further instructed the nurse to use a slip-fit luer syringe to flush the catheter "in" luer with saline.The saline came out pink, and blood-tinged saline was noted in the tubing.This is an indication of a catheter balloon leak.The nurse did not report/suspect how much saline might have had infused into the patient's bloodstream.The nurse was instructed to remove the catheter and disconnect the patient from the thermogard system.The patient's body temperature remained at 94.2 °f during the phone call.After the patient was disconnected from the thermogard system, warming blankets were used to warm the patient.The nurse did not report any device malfunction on the thermogard console.No consequences or impact to the patient.

• 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: 13573568
• Report Number: 3010617000-2022-00166
• Device Sequence Number: 5681456
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IC-4593AE
• Device Catalogue Number: 8700-0660-01
• Device Lot Number: 167692
• 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: 01/29/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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
• Patient Sex: Unknown