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); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the catheter for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
As reported, the quattro catheter (lot # unknown) was placed into the patient's left femoral vein, and a right radial arterial line was also placed for medical purposes.During the rewarming phase, after 6 hours into normothermia, the nurse noted that the 500 ml saline (ns) bag was empty.The user replaced the saline bag and the treatment resumed.However, after about 30 minutes, it was noted that the saline level in the second bag was also decreasing.As per user, there were no traces of fluid on the floor, patient's bed, or around the thermogard console.Catheter leak and infusion of at least 500 milliliters of saline were suspected.There was no blood tinge in the tubing.The catheter was replaced and the patient treatment was completed successfully with the same thermogard console.No consequences or impact to the patient.
Additional Manufacturer Narrative
B5 (describe event or problem) was updated.D4 (additional device information, lot number) was updated.D10 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.The reported complaint of leak on the quattro catheter (lot # 93953) was confirmed during functional testing of the returned catheter.A bonding leak was observed at the distal end of the medial 1 balloon.The probable root cause for the reported complaint could be due to 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 on the catheter's balloons.During functional testing of the returned catheter, 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 bond 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 complaint reported for quattro catheter with lot number 93953.
Event or Problem Description
A patient was admitted for ivtm therapy, and the quattro catheter (lot # 93953) was inserted into the patient's left femoral vein with no unusual resistance noted.A right radial arterial line was also placed for medical purposes.During the rewarming phase, after 6 hours into normothermia, the nurse noted that the 500 ml saline (ns) bag was empty.The user replaced the saline bag, and the treatment resumed.However, after about 30 minutes, it was noted that the saline level in the second bag was also decreasing.There were no traces of fluid observed on the console, patient's bed, or floor around the patient; therefore, a catheter leak and infusion of about 500 milliliters of saline into the patient's bloodstream was suspected.There was no blood tinge noted in the tubing.The catheter was replaced, and the patient treatment was completed successfully with the same 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
• MDR Report Key: 10187130
• Report Number: 3010617000-2020-00620
• Device Sequence Number: 13680056
• Product Code: NCX
• UDI-Device Identifier: 00849111075503
• UDI-Public: 00849111075503
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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: 8700-0791-01
• Device Lot Number: 93953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Received by Manufacturer: 05/30/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1