MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED72 REPERFUSION CATHETER; NRY

Catalog Number	RED72SDKIT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned, and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the distal m1 segment of the middle cerebral artery (mca) using a penumbra system red 72 silver reperfusion catheter (red72 silver) and a penumbra engine (engine).The physician advanced the red72 silver to the face of the clot and initiated aspiration.During the first pass, the physician noticed that there was no flow into the canister so the red72 silver was removed.Upon removal, the the red72 was found to be ovalized with clot in its distal tip and was removed from the procedure.Subsequently, a small clot was identified to have embolized in the m3 and was too distal to aspirate.A microcatheter was then used to deliver a thrombolytic agent (alteplase) and the procedure was completed.There was no additional adverse effect reported.
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 72 silver reperfusion catheter (red72 silver) confirmed that the catheter was ovalized.This type of damage is consistent with the forcefully pinching, gripping, or manipulating the catheter near the hub of the parent device.Based on the reported complaint, the root cause of ovalization could not be determined.Penumbra devices 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.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.

• Brand Name: PENUMBRA SYSTEM RED72 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: 24987442
• Report Number: 3005168196-2026-00147
• Device Sequence Number: 9698617
• Product Code: NRY
• UDI-Device Identifier: 00815948029996
• UDI-Public: 00815948029996
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: RED72SDKIT
• Device Lot Number: F00017136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female