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

Catalog Number	PNS5F130H1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
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 a medical procedure using a neuron select catheter 5f (5f select), a non-penumbra guide catheter, and a guidewire.During the procedure, the physician planned to perform a diagnostic angiogram under general anesthesia.While attempting to advance the 5f select over the guidewire in the right common carotid artery (cca), the physician observed under fluoroscopy that the distal end was unresponsive indicating a fracture.The physician then used a snare device to retrieve the fractured segment.While retracting it through the aorta, the fractured segment could not be stabilized within the guide catheter and migrated into the left external iliac artery.It was then retrieved using a snare device.The procedure was completed using a new 5f select and a benchmark 6f 071 delivery catheter (benchmark).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned neuron select catheter 5f (5f select) confirmed a fracture on the distal end.This type of damage typically occurs if the device is manipulated against resistance during use.Based on the reported complaint, the root cause of resistance could not be determined.Evaluation also revealed damage to the distal tip.This damage is like a result of the multiple attempts to snare the device reported in the procedure.Further evaluation of the returned 5f select revealed bends throughout its length.This damage is likely incidental to the reported complaint.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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22288890
• Report Number: 3005168196-2025-00210
• Device Sequence Number: 8551419
• Product Code: DQY
• UDI-Device Identifier: 00814548010229
• UDI-Public: 00814548010229
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2025

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: 11/28/2025
• Device Catalogue Number: PNS5F130H1
• Device Lot Number: H00001563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 10/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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: 42 YR
• Patient Sex: Female