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

Model Number	CL-2295AE
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the cool line catheter in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
A cool line catheter (lot# unknown) was used for ivtm therapy.It was reported that blood was observed in the catheter balloon, which is an indication of a potential catheter leak.No further information was provided by the customer.Patient's status information was requested, but the customer did not provide a response; therefore, patient's status is unknown.
Additional Manufacturer Narrative
The cool line catheter used at the time of the event will not be returned to zoll for evaluation, as it was discarded by the customer.Therefore, a physical investigation could not be performed, and a root cause could not be determined.Based on the received additional information from the customer, the reported issue with the cool line catheter was due to a user error.The removal of the catheter was done with the in and out luers of the catheter closed, and this caused a rupture in the balloon.Closing the in and out luers does not allow the balloon to drain prior to removal.The trapped saline may have caused a rupture due to the pressure it was exposed to during the removal of the catheter.Per zoll's instructions for use (ifu) for catheter removal, "disconnect the start-up kit from the catheter.Uncap or leave uncapped the saline in and out luers of the catheter.Saline within the balloons must be free to pass out of the balloon or the balloon will not deflate, making the catheter difficult to remove.Do not remove the catheter if resistance is felt.If resistance is felt, repeat the deflation procedure and try removing the catheter again.If resistance is still encountered, an x-ray should be performed to identify the reason for the resistance.".

• 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: 12064819
• Report Number: 3010617000-2021-00535
• Device Sequence Number: 20021569
• Product Code: NCX
• UDI-Device Identifier: 00849111075213
• UDI-Public: 00849111075213
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 07/13/2021

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-2295AE
• Device Catalogue Number: 8700-0781-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1