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	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of leak on the quattro catheter (lot # 96104) was confirmed during functional testing of the returned catheter.A bonding leak was observed at proximal end of 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 catheter was performed and found no physical damage to the catheter.Dried blood residue was observed on the catheter's balloons and in/out luered tubings.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.Immediately upon pressurizing the catheter, a bond leak was observed at the proximal 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 complaint reported for quattro catheter with lot number 96104.
Event or Problem Description
During patient ivtm therapy, the thermogard ivtm system alarmed and displayed an "air trap" message.The saline bag was observed almost empty.Customer disconnected the quattro catheter (lot # 96104) from the start-up kit (suk), and blood tinge was observed in the orange luer.As per customer, the patient was on several blood thinner medications, and there was some blood ooze at the insertion site.Compromised catheter balloon was suspected, and it was suggested to the customer to either over-wire exchange or replace the catheter.However, the physician decided not to place a new quattro catheter, but rather, exchange the quattro for a standard cvc and continue the therapy using alternative method.No known impact or consequence to patient was reported.No device malfunction on the in-use tgxp thermogard console.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9417460
• Report Number: 3010617000-2019-01079
• Device Sequence Number: 534274
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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: 96104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1