MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER; NRY

Catalog Number	RED68KIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system red 68 reperfusion catheter (red68), penumbra system red 43 reperfusion catheter (red43), and a neuron max 6f 088 long sheath (neuron max).The physician advanced the red68 and red43 over the guidewire and into the target location.The red43 and guidewire were removed.The physician began aspiration using the red68 while applying a syringe vacuum to the side port of the rotating hemostasis valve (rhv).While removing the red68 under aspiration, the physician noticed that multiple locations on the distal segment of the red68 were fractured within the rhv.The physician was able to successfully remove the entire fractured red68 and rhv together.It was reported that aspiration was performed to clear the lumen of the neuron max.A follow up angiography was performed that revealed the vessel was opened.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 68 reperfusion catheter (red68) confirmed fractures on the catheter.Due to the lack of torquing or stretching at the fractured locations, this was likely the result of a kink.If the red68 is manipulated at an angle or against resistance during use, the catheter may become kinked and subsequently fracture.Based on the reported event, the root cause could not be determined.Evaluation revealed kinks near the fracture location due to the same manipulation during use.Further evaluation revealed an additional kink near the hub.This damage was incidental to the complaint and may have occurred during packaging of the device for return.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 25299753
• Report Number: 3005168196-2026-00174
• Device Sequence Number: 9319086
• Product Code: NRY
• UDI-Device Identifier: 00815948024113
• UDI-Public: 00815948024113
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K211411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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 Catalogue Number: RED68KIT
• Device Lot Number: H00008701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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