MAUDE Adverse Event Report: CONTEGO MEDICAL, INC PALADIN CAROTID PTA BALLOON SYSTEM; PERCEUTANEOUS CATHETER

Model Number	PD-5530-140-2
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event description a paladin pta iep sys pd-5530-140-2 was attempted to be used but the filter didn't close all the way.No patient complications have been reported as a result of this event.17th feb 2026 additional information received from the rep: the device did not have any filter prep.Each time they would retract the device back after the filter was closed it would start to open again.They were able to pull back a little close the filter more until the device was back inside of the guide catheter where it was removed safely.Investigation: the investigation confirmed that the filter opened and closed normally.There is a potential that the catheter was being stretched during removal accounting for the frame opening.The investigation is ongoing.Conclusions the failure could not be replicated on the returned unit.The returned unit opened and closed normally.This complaint was felt to be clinically insignificant and would be considered very low risk to the patient.

• Brand Name: PALADIN CAROTID PTA BALLOON SYSTEM
• Common Device Name: PERCEUTANEOUS CATHETER
• 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: 24593708
• Report Number: 3011471056-2026-00028
• Device Sequence Number: 10391303
• Product Code: LIT
• UDI-Device Identifier: 00851616007293
• UDI-Public: 00851616007293
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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 Expiration Date: 03/04/2026
• Device Model Number: PD-5530-140-2
• Device Catalogue Number: PD-5530-140-2
• Device Lot Number: Z2460348A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2026
• 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