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

Model Number	SL-2593
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint was not confirmed during the visual and functional testing of the returned solex catheter.No issues or discrepancies were found.No device malfunction was observed during the testing, and the catheter functioned as intended.Visual inspection of the returned catheter was performed.There was no kink, and no physical damage was found on the catheter.Observed blood residue had accumulated/dried up on the catheter's serpentine balloon and luered tubings.Functional testing of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi; no leak and no issues were found.The catheter functioned as intended.An additional guidewire test was performed: a known-good zoll guidewire was slowly inserted through the central lumen of the catheter, starting at the catheter tip, and exited through the distal infusion luer port without resistance.The guidewire could be passed through the entire length of the lumen with no resistance.
Event or Problem Description
An ivtm therapy was initiated for a patient using a solex 7 (lot #unknown) catheter.At the end of the therapy, the nurse reported difficulty removing the catheter.Per the nurse, the catheter was deflated with a slip-tip syringe before being removed, and the luers were left open to the air.The customer experienced difficulty getting close to the distal tip of the catheter while removing it.Approximately one inch was left in the vessel when the customer felt the resistance.Zoll clinical territory associate advised the customer to turn the catheter clockwise and gently remove it.However, the registered nurse and physician assistant continued experiencing resistance even when turning clockwise.Zoll clinical territory associate advised the customer to remove the catheter under fluoroscopy or x-ray.Ir physician assessed the patient and successfully removed the catheter at the bedside.No intervention was taken, no occlusions were found, the patient had no adverse effects after removal, and the catheter insertion site showed no abnormalities post-removal.The dwell time of the catheter was two days.Per the reporter, there was no occlusion or increased tortuosity in the vein.The solex 7 catheter was the only device in the vessel during the time of use.No consequences or impacts on the patient.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19534156
• Report Number: 3010617000-2024-00476
• Device Sequence Number: 12846486
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: 195141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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