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

Model Number	CL-2295
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	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has received the cool line catheter (lot # 96693) for investigation.A follow-up report will be submitted when the investigation has been completed.
Event or Problem Description
During ivtm therapy, the physician placed a first cool line catheter (lot # 96693) into patient's subclavian vein.The user observed blood backing up into the start-up kit (suk) tubing.The physician replaced the first cool line catheter with the second cool line catheter (lot # 96693) and observed blood backing up into the start-up kit (suk) tubing.Suspecting catheter balloon breach.The ivtm treatment was discontinued and the patient treatment was continued with an alternate temperature management method.Per user, the physician chose to use the cool line catheter because the patient had wounds in the groin, and the hospital does not have solex catheter.No device malfunction was reported for the thermogard xp ivtm system.No patient consequence was reported.Please see the following related mfr report: mfr 3010617000-2020-00082 for the second cool line catheter.
Event or Problem Description
During ivtm therapy, the physician placed a first cool line catheter (lot # 96265) into patient's subclavian vein.The user observed blood backing up into the start-up kit (suk) tubing.The physician replaced the first cool line catheter with the second cool line catheter (lot # 96265) and observed blood backing up into the start-up kit (suk) tubing.Suspecting catheter balloon leak.The ivtm treatment was discontinued and the patient treatment was continued with an alternate temperature management method.Per user, the physician chose to use the cool line catheter because the patient had wounds in the groin, and the hospital does not have solex catheter.No device malfunction was reported for the thermogard xp ivtm system.No consequences or impact to the patient was reported.Please see the following related mfr report: mfr (b)(4) for the second cool line catheter.
Additional Manufacturer Narrative
The reported complaint of "the cool line catheter (lot # 96265) balloon leak" was confirmed during the functional testing.A bonding leak was observed at the proximal end of the proximal balloon.The probable root cause for the reported complaint could be due to a latent defect at the bond.Upon visual inspection, noticed dried blood residue on the catheter balloons and on the proximal and in luered tubing's.Also noticed that the out luered tubing was clogged with blood.During functional testing, all infusion ports and extension tubes were flushed without resistance, except the in/out luered tubing's due to the clogged out luered tubing.The catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pinhole leak was observed at the proximal end of the proximal balloon.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 service information related to the reported complaint and there was no previous history of complaint reported for the cool line catheter with lot # 96265.
Additional Manufacturer Narrative
The reported complaint of "the cool line catheter (lot # 96265) balloon leak" was confirmed during the functional testing.A bonding leak was observed at the proximal end of the proximal balloon.The probable root cause for the reported complaint could be due to a latent defect at the bond.Upon visual inspection, noticed dried blood residue on the catheter balloons and on the proximal and in luered tubing's.Also noticed that the out luered tubing's are clogged with blood.During functional testing, all infusion ports and extension tubes were flushed without resistance, except the in/out luered tubings.Experienced resistance in the in/out luered tubings due to the clog accumulation in the out luered tubing.However, upon pressurizing the catheter up to 100psi, a bond leak was observed after 1 minute at the proximal end of the proximal balloon.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 service information related to the reported complaint and there was no previous history of complaint reported for the cool line catheter with lot # 96265.

• 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: 9645193
• Report Number: 3010617000-2020-00081
• Device Sequence Number: 11287864
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• 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,Followup,Followup
• Report Date (Section B): 03/10/2020

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: CL-2295
• Device Catalogue Number: 8700-0781-01
• Device Lot Number: 96265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/03/2020; 02/27/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/19/2020; 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1