MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER; NRY

Catalog Number	RED62S
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 62 reperfusion catheter (red 62) confirmed it was fractured.Evaluation revealed stretching proximal to the fracture location.If the red 62 is retracted against resistance, damage such as stretching and subsequent fracture may occur.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed a kink on the catheter.This damage was incidental to the reported complaint, and the root cause could not be determined.Penumbra devices are visually 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 and m2 segments junction of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red 62), a non-penumbra microcatheter, and a sheath.During the procedure, the physician experienced resistance while making the first pass with the red 62.The physician decided to remove the red 62 from the patient.After removal, the red 62 distal end was noted to be damaged.The entire red 62 was removed from the patient and no longer used in the procedure.The procedure was completed using another red 62, the same microcatheter, and the same sheath.There was no report of an adverse effect to the patient.

• 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 ; 5107483200
• MDR Report Key: 24254311
• Report Number: 3005168196-2026-00038
• Device Sequence Number: 8326700
• Product Code: NRY
• UDI-Device Identifier: 00815948023475
• UDI-Public: 00815948023475
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: RED62S
• Device Lot Number: H00004844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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