MAUDE Adverse Event Report: PENUMBRA, INC. NEURON SELECT CATHETER 5F; DQY

Catalog Number	PNS5F130BER
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing an elective arteriovenous malformation (avm) closure procedure in the cerebral artery using a neuron select catheter 5f (5f select), a benchmark 6f 071 delivery catheter (benchmark), and a guidewire.During the procedure, the physician noticed under fluoroscopy that the distal segment of the 5f select had fractured in the right vertebral artery.The physician then used a snare device to retrieve the fractured segments of the 5f select.The procedure was completed using a new benchmark and other devices.It should be noted that there were no allegations against the first benchmark.
Event or Problem Description
The patient was undergoing an elective arteriovenous malformation (avm) closure procedure in the cerebral artery using a neuron select catheter 5f (5f select), a benchmark 6f 071 delivery catheter (benchmark), and a guidewire.During the procedure, the physician noticed under fluoroscopy that the distal segment of the 5f select had fractured in the right vertebral artery.The physician then used a snare device to retrieve the fractured segment of the 5f select.The procedure was completed using a new benchmark and other devices.It should be noted that there were no allegations against the first benchmark.
Additional Manufacturer Narrative
Please note that the following sections were reported incorrectly on the initial mfr report and are corrected on this follow up mfr report: 1.Section d.Box 4.Lot#.2.Section d.Box 4.Catalog#.3.Section d.Box 4.Unique identifier (udi#).4.Section d.Box 4.Expiration date.5.Section g.Box 2.Report source.6.Section h.Box 4.Device manufacture date.Please note that the following section was updated: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned neuron select catheter 5f (5f select) confirmed it was fractured.This type of damage typically occurs if the device is manipulated or torqued unrestrained against resistance.Based on the reported event, the root cause of resistance during the procedure could not be determined.Further evaluation revealed an additional fracture on the distal segment and damage to the distal tip.This damage is incidental to the reported complaint and likely occurred during snaring or handling post-procedure.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.

• 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 ; 5107483200
• MDR Report Key: 23857883
• Report Number: 3005168196-2025-00412
• Device Sequence Number: 15981708
• Product Code: DQY
• UDI-Device Identifier: 00814548010212
• UDI-Public: 00814548010212
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Expiration Date: 07/30/2026
• Device Catalogue Number: PNS5F130BER
• Device Lot Number: H00003329
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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: 68 YR
• Patient Sex: Male