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

Model Number	IC-4593
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
A patient was hospitalized to receive ivtm therapy after cardiac arrest, and a quattro catheter was inserted into the patient's left femoral vein.The customer reported that the volume of the 500-ml saline bag was noted to be decreasing.The customer did not report at what stage of the treatment the issue was noted and whether the thermogard system displayed an "air trap" alarm.Upon inspection, there were no traces of fluid observed on the console, patient's bed, or the floor.The user observed blood in the start-up kit (suk) tubing, an indication of a potential catheter leak.The catheter was removed, the saline bag was replaced, and a second quattro catheter kit was reopened.Using the new guidewire from the second kit, the customer attempted to insert the catheter into the patient's left femoral vein.As reported, resistance was encountered upon trying to place the catheter over the guidewire.Eventually, the catheter was inserted into the same vein.After an unknown period, the volume of the second saline bag was noted to be decreasing.Subsequently, the second catheter was removed due to a suspected balloon leak.As reported, the removed catheter was checked for balloon leakage.Clear fluid was noted to be draining from the third balloon from the distal tip.The customer did not report when they noticed the second catheter to be leaking or whether the thermogard console displayed an "air trap" alarm.The amount of saline infusion into the patient's bloodstream was suspected to be 250 milliliters.The customer stated that the same thermogard console was used to continue and complete the treatment.This indicates that if an "air trap" alarm was displayed by the console, it must have been cleared by the user to continue the treatment.No consequences or impact to the patient.The two catheters, one with lot number 165913 and one with an unknown lot number, were used during the patient treatment; however, it is unknown which catheter was used first.Please see the following related mfr report: mfr # 3010617000-2021-00935 for the quattro catheter (lot # 165913).
Additional Manufacturer Narrative
The reported complaint of "leak on the quattro catheter (lot # 166228)" was confirmed during functional testing.A bonding leak was observed at the distal end of the medial 1 balloon.The probable root cause of the reported complaint could be a latent defect at the bond.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 luered tubings.During functional testing, all infusion ports and extension tubes were flushed without resistance.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 balloon; thus, 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 information related to the reported complaint, and there was no previous history of complaints reported for the quattro catheter with lot number 166228.
Event or Problem Description
A patient was hospitalized to receive ivtm therapy after cardiac arrest, and a quattro catheter (lot # 166228) was inserted into the patient's left femoral vein following the standard procedure per zoll ifu (instructions for use).A post-procedure x-ray was ordered and confirmed that the catheter was in the correct position.The customer reported that the volume of the 500-ml saline bag was noted to be decreasing.The customer did not report at what stage of the treatment the issue was noted and whether the thermogard system displayed an "air trap" alarm.Upon inspection, there were no traces of fluid observed on the console, patient's bed, or the floor.The user observed blood in the start-up kit (suk) tubing, an indication of a potential catheter leak.The catheter was removed, the saline bag was replaced, and a second quattro catheter (lot # 165913) kit was reopened.Using the new guidewire from the second kit, the customer attempted to insert the catheter into the patient's left femoral vein, following the standard procedure per zoll ifu.As reported, resistance was encountered upon trying to place the catheter over the guidewire.The catheter and guidewire were removed.Using ultrasound guidance, the left femoral vein was cannulated with a finder needle.Immediately upon entering the vein, dark non-pulsatile blood did return.Subsequently, the wire was fed through the needle, and the needle was then removed.Ultrasound was then used to confirm the presence of the guidewire in the vein.A small skin incision was made to allow passage of the dilator, per zoll ifu.After dilation, the catheter was then placed over the guidewire and the guidewire was removed completely.After an unknown period, the volume of the second saline bag was noted to be decreasing.Subsequently, the second catheter was removed due to a suspected balloon leak.As reported, the removed catheter was checked for balloon leakage.Clear fluid was noted to be draining from the third balloon from the distal tip.The customer did not report when they noticed the second catheter to be leaking or whether the thermogard console displayed an "air trap" alarm.The amount of saline infusion into the patient's bloodstream was suspected to be 250 milliliters.The customer stated that the same thermogard console was used to continue and complete the treatment.This indicates that if an "air trap" alarm was displayed by the console, it must have been cleared by the user to continue the treatment.No consequences or impact to the patient.Please see the following related mfr report: mfr # 3010617000-2021-00935 for the quattro catheter (lot # 165913).

• 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: 12545198
• Report Number: 3010617000-2021-00936
• Device Sequence Number: 19705011
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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-4593
• Device Catalogue Number: 8700-0660-01
• Device Lot Number: 166228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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