MAUDE Adverse Event Report: ZOLL CIRCULATION INC ZOLL IVTM ICY CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-3893
Medical Device Problem Codes	Fluid/Blood Leak (1250); Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that on (b)(6) 2023 at 19:00, during preparation for ivtm therapy, they could not use icy catheter #1 (lot unknown) because of the balloon damage.The customer replaced the damaged catheter with another icy catheter #2 (lot unknown), but the replaced catheter also could not be used because of the balloon damage.The balloon damage was found before insertion of the catheters during the leak check of the catheters.After replacing with a new catheter again, the customer could begin the ivtm therapy with no further issues.Therapy ended on (b)(6) 2023 with no issues.No patient injury was reported.Please see the following related mfr report: mfr #3010617000-2023-00721 for the icy catheter #1.
Additional Manufacturer Narrative
Zoll has not received the icy catheter for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The customer reported that on (b)(6) 2023 at 19:00, during preparation for ivtm therapy, they could not use icy catheter #1 (lot 184646) because of the balloon damage.The damage resulted in catheter leakage.The customer replaced the damaged catheter with another icy catheter #2 (lot 184646), but the replaced catheter also could not be used because of the balloon damage.The balloon damage was found before insertion of the catheters during the leak check of the catheters.After replacing with a new catheter again, the customer could begin the ivtm therapy with no further issues.Therapy ended on (b)(6) 2023 with no issues.No patient injury was reported.
Additional Manufacturer Narrative
The reported complaint that the icy catheter #2 (lot 184646) had balloon damage was confirmed during functional testing.A leak from the middle of the medial balloon due to a balloon tear was observed during the functional in/out lumen test.The probable root cause for the reported complaint could be that the catheter balloon was torn during handling of the catheter.Visual inspection of the returned catheter was performed, and no physical damage was found on the catheter.Functional testing was performed, all infusion ports and lumen were flushed without resistance.Upon flushing the in/out lumen, a leak from the middle of the medial balloon was observed, confirming the reported complaint.During further inspection of the catheter under a microscope, a balloon tear was observed at the middle of the medial balloon.Pressurized functional testing could not be performed due to the leak discovered during the in/out lumen test.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 were no similar complaints reported for the icy catheter with lot number 184646.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17627312
• Report Number: 3010617000-2023-00722
• Device Sequence Number: 7386097
• Product Code: NCX
• UDI-Device Identifier: 00849111075527
• UDI-Public: 00849111075527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/20/2023

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: IC-3893
• Device Catalogue Number: 8700-0782-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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