MAUDE Adverse Event Report: Penumbra, Inc. Penumbra System RED 62 Reperfusion Catheter; NRY

Catalog Number	RED62SKIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left m2 segment of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a non-penumbra guide catheter (7f), a non-penumbra catheter (5fr), and a non-penumbra sheath (7fr), and a guidewire (.035).The physician advanced the guide catheter and 5fr catheter to the target location.The 5fr catheter was then removed and an angiogram was performed.The physician advanced the guide catheter and 5fr catheter to the target location and performed an angiogram after removal of the 5fr catheter.The red62 and guidewire were then advanced to the thrombus.Following removal of the guidewire, aspiration was initiated using a 60ml syringe and the red62.During retraction, the red62 was noted to be fractured while passing through the hemostasis valve.The guide catheter and red62 were subsequently removed together from the patient.On the back table, resistance was encountered while attempting to remove the red62 from the guide catheter.The procedure was completed with a penumbra system red 43 reperfusion catheter (red43) and the same guide catheter.A post-procedure ct scan revealed a left-sided subarachnoid hemorrhage (sah); however, no treatment was required.The physician reported that the sah was most likely secondary to a vessel dissection caused by vessel stress during stretching of the red62 catheter in the m2 segment.It was reported that the patient was doing well post-procedure with no neurological deficits.
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 62 reperfusion catheter (red62) confirmed that the catheter was stretched and fractured.If the red62 is retracted against resistance, damage such as stretching and subsequent fracture may occur.Based on the reported complaint, the root cause of could not be determined.Further evaluation revealed that the catheter had additional fractures.This damage was incidental to the reported complaint and was likely due to being cut after removal of the red62 from the procedure.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 62 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 ; +1(510)748-3200
• MDR Report Key: 50885578
• Report Number: 3005168196-2026-00327
• Device Sequence Number: 13202124
• Product Code: NRY
• UDI-Device Identifier: 00815948023536
• UDI-Public: 00815948023536
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203440
• 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): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RED62SKIT
• Device Lot Number: H00010873
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female