MAUDE Adverse Event Report: CONTEGO MEDICAL, INC PALADIN SYSTEM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number	PD-5030-140-2
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: it was reported that during treatment of a calcified lesion in the left carotid artery using the paladin percutaneous transluminal angioplasty iep sys, difficulty was noted during deployment.Artery diameter reported as 4-6 mm.A non-medtronic (silk road tcar) sheath and a 90 cm 014 non-medtronic (silk road) guidewire were used.The vessel was pre-dilated with a non-medtronic (silk road tcar) balloon.The vessel was post-dilated with the 5x30 mm paladin pta iep device.It was reported that the thumbwheel that opens and closes the filter was not functioning properly, and the physician was not able to fully deploy the filter.The physician used the paladin balloon to post-dilate the lesion without opening up the filter.The device was safely removed from the patient.No patient complications have been reported as a result of this event.Investigation: the product was not returned, therefore an investigation into the actual product could not be performed.A review of the lot history record (lhr) was conducted.No manufacturing deviations, processing anomalies, or quality issues were identified that could have contributed to the reported inability to deploy the filter.Conclusions: the exact cause of the alleged reported inability to fully deploy the filter can not be determined.This mdr report is being filed as a conservative measure.

• Brand Name: PALADIN SYSTEM
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): CONTEGO MEDICAL, INC; 3801 lake boone trail,; suite 100; raleigh
• Manufacturer (Section G): CONTEGO MEDICAL; 3801 lake boone trail,; suite 100; raleigh
• MDR Report Key: 24636003
• Report Number: 3011471056-2026-00034
• Device Sequence Number: 9014975
• Product Code: NTE
• UDI-Device Identifier: 00851616007002
• UDI-Public: 00851616007002
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K221339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: PD-5030-140-2
• Device Catalogue Number: PD-5030-140-2
• Device Lot Number: Z2460593A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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