MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU; INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER

Model Number	SL-2593AE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
While attempting to insert the solex 7 catheter (lot #186920) into the patient's right femoral vein, the insertion site was well dilated, and the guidewire advanced smoothly.However, the catheter was found to be kinked.Consequently, the catheter was neither inserted nor replaced.No intervention was necessary or planned.The customer did not provide any further information.The patient is alive without any reported injury.
Additional Manufacturer Narrative
The reported complaint of a kinked catheter was confirmed during the visual inspection of the returned solex 7 catheter.The catheter was returned to zoll with its shaft completely damaged.The shaft was observed to be kinked at two locations on the serpentine balloon.The exact timing and cause of the kink on the catheter cannot be determined, however, user handling of the catheter cannot be ruled out.During visual inspection, the catheter shaft was observed to be kinked at two locations on the serpentine balloon, located 2.5 cm and 7.5 cm away from the catheter tip.Functional flushing of the catheter was performed.All infusion ports and lumens were flushed without resistance, except for the in/out lumen due to the severe kink on the serpentine balloon.Due to the condition in which the catheter was received, the functional pressure leak test could not be performed.Historical complaints were reviewed for investigation results related to the reported complaint, and there was no previous history of complaints reported for the solex 7 catheter with lot number 186920.

• Brand Name: SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU
• Common Device Name: INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 20243031
• Report Number: 3010617000-2024-00754
• Device Sequence Number: 12571589
• Product Code: NCX
• UDI-Device Identifier: 00849111075312
• UDI-Public: 00849111075312
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/17/2024

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 Expiration Date: 02/23/2025
• Device Model Number: SL-2593AE
• Device Catalogue Number: 8700-0793-40
• Device Lot Number: 186920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2023
• 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
• Patient Weight: 71 KG