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

Model Number	PD-5520-140-2
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: it was reported that during a procedure to treat plaque in the mid right carotid artery using the paladin percutaneous transluminal angioplasty iep system, there was a delay in surgery of three minutes due to a product issue.The artery diameter was 5.5mm with moderate tortuosity.A 6fr sheath and a.035 guidewire were used.A embolic protection device was used.The vessel was post-dilated.No resistance was encountered when advancing the device.It was reported that the paladin filter would not open.The device was safely removed, and the procedure was completed using a new paladin 5.0x20 device.No patient complications have been reported as a result of this event.Investigation: the preliminary investigation determined that the filter could not be opened with a guidewire in place.Conclusions the mechanism to actuate the filter did not perform as expected.The device was safely removed and a second paladin device was successfully used.There were not patient complications as a result of this of the event.

• 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: 24918445
• Report Number: 3011471056-2026-00057
• Device Sequence Number: 21437565
• Product Code: NTE
• UDI-Device Identifier: 00851616007477
• UDI-Public: 00851616007477
• Combination Product (Y/N): N
• 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): 04/17/2026

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-5520-140-2
• Device Catalogue Number: PD-5520-140-2
• Device Lot Number: Z2460817A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/17/2026
• 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