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

Catalog Number	PNS5F130SIM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2026
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 coil embolization procedure in the middle meningeal artery (mma) using a neuron select catheter 5f (5f select), a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra sheath (6f), and a guidewire (0.038).The physician gained right radial access and advanced the benchmark and the 5f select through the sheath over the guidewire to the aortic arch.The benchmark was then placed in the subclavian artery.While selecting the ica using the 5f select, the physician observed that the 5f select appeared to be damaged under fluoroscopy.The physician decided to remove 5f select.While retracting the 5f select, the 5f select fractured at the distal end in the aortic arch.The 5f select was removed and the fractured portion remained in the aortic arch while the physician continued the coil embolization procedure using another 5f select.After completion of the coil embolization procedure, the physician gained right femoral access and a 9f sheath was placed.The physician advanced a snare device to retrieve the fractured 5f select segment.While retracting into the sheath, the physician observed under fluoroscopy that the 5f select fractured at the distal end and two small fragments fell downstream into the muscular branches near the sfa.The physician determined it was safe to leave the remaining fragments in the muscular branches as there was no obstruction.The procedure was completed at this point.It was reported that the patient was doing well next day.
Additional Manufacturer Narrative
Evaluation of the returned neuron select catheter 5f (5f select) confirmed that the catheter was fractured.This type of damage is consistent with the device being advanced or torqued unrestrained against resistance.Based on the reported event, the root cause of resistance during the procedure could not be determined.Further evaluation of the 5f select revealed damage and an additional fracture on the device.This damage likely occurred during snaring for removal.The distal fractured fragment was not returned for evaluation.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.

• 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: 24654851
• Report Number: 3005168196-2026-00091
• Device Sequence Number: 5763373
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 00814548010236
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Expiration Date: 05/11/2026
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: H00002811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male