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

Model Number	CL-2295
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
During ivtm therapy, customer reported that balloons leakages were observed on the icy catheter (lot #unknown) and cool line catheter (lot #unknown).No known impact or consequence to patient information was available.
Additional Manufacturer Narrative
The reported complaint of the cool line catheter leak was confirmed.The investigation findings revealed a pinhole leak at middle of distal balloon during functional pressure leak test.The root cause of the reported event was due to a latent material defect.Visual examination of the returned cool line catheter was performed and found no physical damage to the catheter.Observed blood residue in the balloons and also in the distal, medial, proximal and in/out luered tubings.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance, except the medial and in/out luers ports were clogged with blood.During functional testing, the catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pinhole leak was observed at the distal end of distal balloon, 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 service information related to the reported complaint and there was no previous history of complaint reported for cool line catheter with lot number 84469.

• Brand Name: ZOLL IVTM COOL LINE CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8375005
• Report Number: 3010617000-2019-00134
• Device Sequence Number: 1599275
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup
• Report Date (Section B): 06/11/2019

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: CL-2295
• Device Catalogue Number: 8700-0654-01
• Device Lot Number: 84469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1