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	05/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the quattro catheter (lot # 82372) leak was confirmed during the functional testing.A pin hole leak on the shaft was observed.The probable root cause could be due to a latent material defect.Upon visual inspection, no evident physical damage was observed on the catheter.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.During functional testing, the catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pinhole leak on the shaft was observed at 2 cm away from the distal end of manifold.The catheter was inspected under the microscope to confirm the pinhole noted during functional leak test, thus confirming customer complaint.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 similar complaint reported for the quattro catheter with lot # 82372.
Event or Problem Description
During patient use, the user observed decreasing saline volume in the saline bag.The user was unable to identify the location of the leak.Replaced both the start-up kit (suk) and the quattro catheter to continue the treatment.No additional information was provided.No known impact or consequence to 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
• MDR Report Key: 8679454
• Report Number: 3010617000-2019-00459
• Device Sequence Number: 2005615
• Product Code: NCX
• UDI-Device Identifier: 00849111050050
• UDI-Public: 00849111050050
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2019

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: 8700-0783-03
• Device Lot Number: 82372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1