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

Model Number	CL-2295AE
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll cool line catheter was not returned to zoll for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The patient was admitted for a multi-organ harvest.Zoll cool line catheter (lot #161437) was inserted by a physician smoothly, at the first attempt.The cool line catheter was utilized during the patient preparation for a ct scan.The high-pressure pump was used to administer the contrast agents through the distal infusion port of the cool line catheter.The distal infusion port tubing burst next to the distal luer after the user applied the contrast fluid.To reduce the risk of pulmonary embolism, the infusion line was clamped and upon return to the intensive care unit, the knot was tied and a plug was fitted to the line.Following this, the cool line catheter was replaced and the regular central venous catheter (cvc) line was placed.The customer stated that the catheter's distal lumen did not resist to the pressure during the injection of the contrast product and the distal tubing split in to two just below the luer.
Event or Problem Description
The deceased organ donor was admitted for a multi-organ harvest.Zoll cool line catheter (lot # 160832) was inserted in the right internal jugular vein by a physician smoothly, at the first attempt.The cool line catheter with the thermogard console was used for 3 hours for ivtm therapy during the patient preparation for a ct scan with the application of sodium chloride (nacl) vein guard solution through one of the cool line catheter infusion ports.The bayer medrad injector high-pressure pump was used to administer the contrast agents through the medial infusion port of the cool line catheter at the 3cc/second rate.A total of 90cc of contrast medium were injected.The medial infusion port tubing burst next to the medial luer during the injection of the contrast fluid.To reduce the risk of pulmonary embolism, the infusion line was clamped and upon return to the intensive care unit, the knot was tied and a plug was fitted to the line.Following this, the cool line catheter was replaced and the regular central venous catheter (cvc) line was placed.The customer stated that the catheter's medial lumen did not resist to the pressure during the injection of the contrast product and the medial tubing split into two just below the luer.
Additional Manufacturer Narrative
The reported cool line catheter issue was confirmed based on visual inspection.The medial luered tubing was torn/ruptured as received.Probable causes for the reported complaint was due to the high-pressure introduction caused by the use of a high-pressure pump.Cool line catheter instructions for use warn against using pressure exceeding 100 psi.Visual examination of the returned catheter was performed and found the medial infusion port was clamped and tied as a knot.After the knot was removed, the tubing was observed torn, ruptured, and split into two.The tear was measured 2cm, located at the distal end of medial luer due to the high-pressure introduction likely caused by the use of the high-pressure pump during the contrast agents injection.Noticed blood residue in the medial luered tubing.No other physical damage was observed on the catheter.Functional testing of the returned catheter was performed.The distal and proximal infusion ports and extension tubes were flushed without resistance.The catheter was connected to a pressurized inflation device, the balloons fully inflated when pressurized up to 100 psi without any issues.No leak was observed.The balloons did not leak during testing.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 information related to the reported complaint, and there was no previous history of complaint reported for cool line catheter with lot number 160832.

• 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
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131
• MDR Report Key: 12663211
• Report Number: 3010617000-2021-00962
• Device Sequence Number: 14511353
• Product Code: NCX
• UDI-Device Identifier: 00849111075213
• UDI-Public: 00849111075213
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 160832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown