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

Catalog Number	RED72
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2025
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 right middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a penumbra system ace 68 reperfusion catheter (ace68), a non-penumbra long sheath, a non-penumbra microcatheter, a stent retriever, and a guidewire.During the procedure, after performing two passes in the target location using the ace68, the occlusion opened slightly.The physician then decided to remove the ace68 and exchange it for a red72.While performing the next pass using the red72, the physician attempted to aspirate and retract the red72; however, resistance was encountered and the red72 was not moving.The physician made another attempt to retract the red72 and fractured it on the distal length within the mca.Attempts were made to remove the fractured segment of the red72 using a snare device, then a stent retriever, and by advancing the long sheath close to the target location, without success.After multiple unsuccessful attempts to remove the fractured segment of the red72, the physician decided to stop the procedure.The physician then performed a left side angiogram and reported that the flow was good, but the flow on the right side was slow.The patient was then transferred to the intensive care unit (icu).It was reported that there is no plan to remove the fractured segment of the red72.It was reported on (b)(6) 2025, that the patient was placed on a ventilator due to multiple diseases.
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 72 reperfusion catheter (red72) confirmed a fracture on the distal end and revealed stretching at the fractured location.If the red72 is retracted against resistance during use, damage such as stretching and a subsequent fracture may occur.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation revealed kinks and ovalizations on the distal end.This damage was incidental to the reported complaint and may have occurred during removal of the device from the patient or packaging for return to penumbra.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a penumbra system ace 68 reperfusion catheter (ace68), a non-penumbra long sheath, a non-penumbra microcatheter, a stent retriever, and a guidewire.During the procedure, after performing two passes in the target location using the ace68, the occlusion opened slightly.The physician then decided to remove the ace68 and exchange it for a red72.While performing the next pass using the red72, the physician attempted to aspirate and retract the red72; however, resistance was encountered and the red72 was not moving.The physician made another attempt to retract the red72 and fractured it on the distal length within the mca.Attempts were made to remove the fractured segment of the red72 using a snare device, then a stent retriever, and by advancing the long sheath close to the target location, without success.After multiple unsuccessful attempts to remove the fractured segment of the red72, the physician decided to stop the procedure.The physician then performed a left side angiogram and reported that the flow was good, but the flow on the right side was slow.The patient was then transferred to the intensive care unit (icu).It was reported that there is no plan to remove the fractured segment of the red72.It was reported on (b)(6) 2025, that the patient was placed on a ventilator due to multiple diseases.The patient has since recovered and is doing well.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra distributor on 01/21/2026: 1.Section b.Box 5.Describe event or problem.

• 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: 23812490
• Report Number: 3005168196-2025-00399
• Device Sequence Number: 15943481
• Product Code: NRY
• UDI-Device Identifier: 00815948023918
• UDI-Public: 00815948023918
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2026

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: RED72
• Device Lot Number: H00005499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 01/21/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/22/2026; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male