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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
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, it was noted that blood was observed in the start-up kit (suk) and the saline bag had decreased.The thermogard console (serial #unknown) generated an alarmed.The catheter placement was into the patient's femoral vein.The cool line catheter (lot #unknown) suspected to be leaking and it was removed.A new catheter was placed to continue with therapy.No consequences or impact to patient.Please see the following related mfr report: mfr 3010617000-2021-00814 for thermogard console.
Additional Manufacturer Narrative
The reported complaint of a icy catheter leak was confirmed during functional testing.A bonding leak was observed at proximal end of medial balloon during pressure leak test.The probable root cause could be due to a latent defect of the bond.Upon visual inspection, no physical damage was observed on the catheter.Noticed blood residues in the balloons and luered tubings.The returned catheter was connected to the pressurized inflation device and upon pressurizing the catheter up to 100 psi, a bonding leak was observed at proximal end of medial balloon.Thus confirming the reported complaint.During manufacturing, all icy catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.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 149259.

• 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: 12349537
• Report Number: 3010617000-2021-00748
• Device Sequence Number: 12044838
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR