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

Model Number 8700-0783-03

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of a leak in the quattro catheter (lot 185455) was confirmed during the functional testing of the catheter.A leak was observed from the proximal end of the distal balloon due to a tear in the balloon.The probable root cause of the reported complaint was a latent material defect.Visual inspection of the returned catheter was performed, and no physical damage was found on the catheter.Blood residue was observed in the distal balloon.During functional testing, all infusion ports and lumen were flushed without resistance.Upon flushing the in/out lumens, a leak was observed from the proximal end of the distal balloon.During further inspection of the catheter under a microscope, a balloon tear was observed, located 1.5 cm away from the proximal end of the distal balloon, confirming the reported complaint.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 quattro catheter with lot 185455.

Event Description

On (b)(6) 2024, ivtm therapy using the quattro catheter (lot 185455) for the post cardiac arrest patient began.At the start of therapy, the patient's blood pressure increased from 110 to 160.The causal relationship is unknown.No information was provided about any treatment used to lower the patient's blood pressure.After about 2 hours of ivtm therapy, the air trap error occurred.The saline bag was empty, and there was air in the air trap.Since it was not possible to confirm that saline was leaking around the console, the customer determined that it was caused by a catheter leak.The customer confirms following the catheter ifu.The catheter and start-up kit (suk) were replaced to continue treatment with the same console.No device malfunction was observed on the suk.Once the catheter was removed from the patient, the customer used a saline bag to determine the location of the leak.The customer painted a red marker over the suspected leaking point of the catheter.No patient injury reported.The patient is in stable condition.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Type of Device: 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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19006050
• MDR Text Key: 339011162
• Report Number: 3010617000-2024-00277
• Device Sequence Number: 1
• Product Code: NCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2024

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
• Device Operator: Health Professional
• Device Model Number: 8700-0783-03
• Device Catalogue Number: 8700-0783-03
• Device Lot Number: 185455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1