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

Model Number	SL-2593
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
After 6 days of ivtm therapy utilizing the solex 7 catheter (lot# unknown), the 500ml saline bag was observed empty (about 250ml of saline had been infused).The physician elected to remove the catheter and fever management therapy was not resumed as the patient reached the target temperature.Upon removal of the catheter, it was reported that there was a leak observed in the balloon.Per the reporter, the catheter was smoothly inserted in the left internal jugular vein on the first attempt.No consequences or impact to the patient.
Additional Manufacturer Narrative
The zoll solex 7 catheter was returned to zoll for evaluation, however, the investigation is pending.A follow up report will be filed when the investigation has been completed.
Event or Problem Description
After 6 days of ivtm therapy utilizing the solex 7 catheter (lot# 171267), the 500ml saline bag was observed empty (about 250ml of saline had been infused).The physician elected to remove the catheter and fever management therapy was not resumed as the patient reached the target temperature.Upon removal of the catheter, it was reported that there was a leak observed in the balloon.Per the reporter, the catheter was smoothly inserted in the left internal jugular vein on the first attempt.No consequences or impact to the patient.
Additional Manufacturer Narrative
The reported complaint of "the solex 7 catheter (lot # 171267) leak" was confirmed during the functional testing.A pinhole leak was observed at the proximal end of the serpentine balloon during the functional pressure leak test.The probable root cause of the pinhole leak was a latent material defect.A visual examination of the returned catheter was performed, and no physical damage was found on the catheter.Noticed dried blood residues on the catheter's serpentine balloon and luered tubings.A functional leak test of the returned catheter was performed, and all infusion ports and lumens were flushed without resistance.The catheter was connected to a pressurized inflation device during the functional pressure leak test.Upon pressurizing the catheter up to 100 psi, a pinhole leak was observed at the proximal end of the serpentine balloon, thus 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 following process.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for the solex 7 catheter with lot # 171267.

• 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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16465429
• Report Number: 3010617000-2023-00196
• Device Sequence Number: 7579087
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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: 171267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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