MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SOLEX 7 CATHETER; CENTRAL VENOUS CATHETER

Model Number	SL-2593
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	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "suspected a possible solex 7 catheter (lot #178732) leak" was confirmed during the functional testing of the returned catheter.A pinhole leak was observed at the proximal end of the serpentine balloon during the functional in/out lumen test.The probable root cause of the pinhole leak was a latent material defect.Visual inspection of the returned catheter was performed, and no physical damage was found on the catheter.Observed blood residues in the serpentine balloons and luered tubings.Functional testing was performed, all infusion ports and lumen were flushed without resistance, except for the distal and medial luer due to blood clogging.During the in/out lumen test, a pinhole leak was observed at the proximal end of the serpentine balloon, thus, 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.All catheters are 100% inspected for leaks during manufacturing by subjecting them to pressure testing.Only units that passed are moved to the following process.Historical complaints were reviewed for information related to the reported complaint, and there was no previous complaint history reported for solex 7 catheter with lot #178732.
Event or Problem Description
During ivtm therapy, customer reported that the thermogard console (sn (b)(6)) generated an "air trap" warning alarm and blood-tinge was noticed in the solex 7 catheter and start-up kit (suk) (lot #191220) tubing.The 1000ml saline bag was noted half full.Customer suspected a possible solex 7 catheter (lot #178732) leak.The solex 7 catheter was removed, and treatment discontinued.It was noted that the catheter had no visible damage after it was removed from the patient.The catheter insertion was at the patient's right subclavian vein without any issue.Catheter dwell time was 48 hours.Per reporter, a 1000ml saline bag was used rather than a 500ml saline bag due to lack of availability.The thermogard console is functioning properly.No consequences or impact to the patient.
Additional Manufacturer Narrative
Correction made on the catheter manufacturing date in section h4.

• Brand Name: ZOLL IVTM SOLEX 7 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: kim nguyen ; 2000 ringwood ave; san jose, CA 95131
• MDR Report Key: 17628750
• Report Number: 3010617000-2023-00728
• Device Sequence Number: 14973310
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2023

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: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: 178732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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