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

Catalog Number	RED72SDKIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left m1 segment of the mca using a penumbra system red 72 silver reperfusion catheter (red72 silver), a sendit delivery device (sendit), a benchmark bmx96 access system (bmx96), and a guidewire.The physician placed the bmx96 in the common carotid artery (cca) and performed a contrast run.The red72 silver and the sendit were advanced to the face of the clot.While retracting the sendit from the red72 silver, the physician experienced resistance.The sendit and the red72 silver were removed together.After removal, the physician noticed multiple kinks on the distal end of the red72 silver.The physician advanced a new red72 silver and sendit to the target location.The sendit was removed to initiate aspiration.After three minutes of aspiration no clot was aspirated.The red72 silver was removed and found to be fractured at the distal end.The proximal portion was removed from the patient.The remaining portion extended from the m1 segment to the external carotid artery (eca).Multiple attempts were made to remove the remaining portion of the red72 silver using a snare device.The remaining portion of the red72 silver was left in the patient.There are currently no plans to remove the fractured red72 silver.It was reported that there was improved flow post-procedure.The patient remained in the intensive care unit (icu).On (b)(6) 2026, it was reported that the patient was transferred to a rehabilitation facility and is doing well.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

• Brand Name: PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (SILVER)
• 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: 25700455
• Report Number: 3005168196-2026-00224
• Device Sequence Number: 21250095
• Product Code: NRY
• UDI-Device Identifier: 00815948029996
• UDI-Public: 00815948029996
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• 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): 07/02/2026

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: RED72SDKIT
• Device Lot Number: F00018240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female