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

Model Number	CL-2295
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cool line catheter associated with this complaint was not returned for evaluation.The product was disposed.Since the device was not returned, an investigation could not be performed and a root cause could not be determined.Event was not serious because surgical treatment of hematomas not reported.Event of catheter insertion difficulty and hematomas at insertion site were probably related to zoll catheter due to the relevant location and timing.Clinical condition of clotting issues in this patient possibly contributed to the event as well.
Event or Problem Description
During catheterization for a critically ill patient with clotting issues, the trauma surgeon experienced difficulty while trying to place a cool line catheter (lot # unknown) into the patient's subclavian vein.The patient had some hematomas on the site after the surgeon tried insertion attempts to place the cool line catheter.After few attempts, the surgeon decided to place a quattro catheter (lot # unknown) into the patient's femoral vein and was able to place the catheter successfully to treat the patient.In addition, the surgeon reported guidewire (lot # unknown) being "flimsy." per the customer, there was no device malfunction on the catheters.

• 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: 11469094
• Report Number: 3010617000-2021-00242
• Device Sequence Number: 3624889
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1