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

Model Number	IC-3893AE
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	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a leak from the luer of the icy catheter (lot 188004) was confirmed during functional testing.A water emission/leak was observed from the in luer during the lumen crosstalk test.The probable root cause is a weakened wall between the lumens, which withstood pressure testing during manufacturing but resulted in a leak during clinical use.Visual inspection of the returned catheter was performed and the distal infusion luered tubing was observed to be completely cut off by customer (1 inch away from proximal end of manifold).Blood residues were observed on the balloons and luered tubings.No other physical damage was observed on the catheter.Functional testing of the returned catheter was performed.All lumens were flushed without resistance, except the distal luer due to the observed damage.During the functional pressure leak test, the returned catheter was connected to the pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi, no leak was observed from the catheter balloons.However, a water emission/leak was observed from the in luer during the lumen crosstalk test; confirming the reported complaint.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 188004.
Event or Problem Description
On 12/20/2023, ivtm therapy began for the patient.Immediately after starting therapy, the saline began leaking from the luer of the start-up kit (suk) (lot 191352).The customer did not tighten the luer too much but felt it did not mesh well.The suk was replaced with a new one, but the luer leak issue was not resolved.Upon follow up, the leaking luer was due to the icy catheter (lot 188004).Subsequently, the catheter was replaced with a new one to continue therapy.The same console was used to continue therapy using the second suk and catheter.No patient injury was reported.

• 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: 18661026
• Report Number: 3010617000-2024-00159
• Device Sequence Number: 15252567
• Product Code: NCX
• UDI-Device Identifier: 00849111050043
• UDI-Public: 00849111050043
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

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-3893AE
• Device Catalogue Number: 8700-0657-03
• Device Lot Number: 188004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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