MAUDE Adverse Event Report: Penumbra, Inc. Neuron Select Catheter 5F; DQY

Catalog Number	PNS5F130BER
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/30/2026
Type of Reportable Event	Death
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a neuron select catheter 5f (5f select).The physician was advancing the 5f select in the cervical area and reported that it fractured on the distal length in the common carotid artery (cca).Several attempts were made to retrieve the fractured segment of the 5f select using a snare device; however, they were unsuccessful.A balloon device was then used; however, the fractured segment migrated distally.The physician decided to continue the thrombectomy procedure using a stent retriever.After the thrombectomy was completed, the physician found that the 5f select segment had broken into several smaller fragments.Further attempts were made to retrieve the remaining 5f select fragments, without success.Some fragments remained in the internal carotid artery (ica).The physician decided to terminate the procedure at this point.It was reported that the patient expired the following day on (b)(6) 2026.The cause of death is unknown.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: Neuron Select Catheter 5F
• Common Device Name: DQY
• 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 ; +1(510)748-3200
• MDR Report Key: 50453404
• Report Number: 3005168196-2026-00279
• Device Sequence Number: 16022675
• Product Code: DQY
• UDI-Device Identifier: 00815948027893
• UDI-Public: 00815948027893
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K083125
• 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): 08/26/2026

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: PNS5F130BER
• Device Lot Number: H00005759
• 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: 07/30/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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: Death; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male