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

Model Number	IC-3893CO
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of icy catheter (lot #148834) leak was confirmed during functional testing.A pinhole leak was observed at distal end of distal balloon.The probable root cause of the pin hole leak was due to latent material defect.Visual examination of the returned icy catheter was performed and found no physical damage.Blood residue was observed on the balloons and on the medial luer tubing of the returned icy catheter.Functional testing of the returned catheter was performed.All infusion other infusion ports and extension tubes were flushed without resistance.The catheter was connected to a pressurized inflation device.Upon pressurizing the icy catheter, a pinhole leak was observed at distal end of distal balloon.Thus, confirming the reported 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.The investigation findings determined that the probable cause of the reported issue was due to a latent material defect.Therefore, it is unlikely that the catheter was defective when shipped.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for icy catheter with lot number 148834.
Event or Problem Description
During ivtm therapy, a hospital physician noticed blood in the flow indicator on the start-up kit (suk) and suspected a icy catheter (lot #148834) leak.The physician removed the catheter and inserted a new catheter to continue with ivtm treatment.Issue was noticed around half an hour during treatment.Patient's status information was requested but the customer did not provide a response, therefore patient's status is unknown.

• Brand Name: ZOLL IVTM XXX CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 10731532
• Report Number: 3010617000-2020-01054
• Device Sequence Number: 3456540
• Product Code: NCX
• UDI-Device Identifier: 00849111075527
• UDI-Public: 00849111075527
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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-3893CO
• Device Catalogue Number: 8700-0782-14
• Device Lot Number: 148834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1