MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Catalog Number	RED72SDKIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 72 silver reperfusion catheter (red72 silver) confirmed that the catheter was fractured and revealed stretching at the fracture site.If the red72 silver is retracted against resistance, damage such as stretching and a subsequent fracture may occur.Based on the reported complaint, the patient¿s tortuous anatomy may have contributed to resistance during the procedure.Further evaluation of the device revealed kinks distal to the stretching, supporting that the device likely became pinned within the tortuous patient anatomy during the procedure and contributed to resistance during retraction.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system red 72 silver reperfusion catheter (red72 silver), a sendit delivery device (sendit), a neuron max 6f 088 long sheath (neuron max), and a guidewire.The patient¿s anatomy was noted to be tortuous.The red72 silver and sendit were advanced over a guidewire and through the neuron max to the target location, and aspiration was performed.The physician decided to retract the red72 silver.While retracting the red72 silver, the physician experienced resistance.The rhv was checked and confirmed not to be overly tightened.The physician continued to retract the red72 silver, and noticed that the distal tip was not moving.The red72 silver and neuron max were subsequently removed together from the patient.On the back table, the distal end of the red72 silver was observed to be unraveling within the neuron max.The red72 silver was not used for the remainder of the procedure.The procedure was completed using a new red72, the same sendit, and the same neuron max.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED 72 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: 25609260
• Report Number: 3005168196-2026-00214
• Device Sequence Number: 18592402
• Product Code: NRY
• UDI-Device Identifier: 00815948029996
• UDI-Public: 00815948029996
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K242104
• 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): 06/24/2026

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: RED72SDKIT
• Device Lot Number: F00018238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2026
• Initial Report FDA Received Date: 06/24/2026
• 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 Age: 86 YR
• Patient Sex: Female