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

Catalog Number	PNS5F130SIM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure in the right common carotid artery (cca) using benchmark 6f 071 delivery catheters (benchmarks), a neuron select catheter 5f (5f select), and a radial introducer sheath.During the procedure, the physician used the 5f select to guide the benchmark into the target vessel via radial approach.While attempting to retract the 5f select, the physician noticed that the 5f select was not responding to movements and decided to remove it.Upon removal, it was noticed that the distal length of the 5f select was fractured inside the benchmark.The benchmark was then removed with the fractured segment of 5f select.The benchmark was found to be kinked at the distal length after removal.The physician then opened a new benchmark and found that it was leaking at the proximal length while flushing the benchmark before insertion into the patient.Therefore, the benchmark was not used with the patient.The procedure was completed using another catheter and the same radial introducer sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned neuron select catheter 5f (5f select) confirmed that the catheter was fractured.This damage typically occurs if the 5f select is retracted against resistance during use.It was reported that the benchmark used in the procedure was kinked on its distal length.This damage may have contributed to resistance during retraction of the 5f select and caused the 5f select to fracture.The distal fractured segment was not returned for evaluation.Penumbra catheters are visually 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: 22010980
• Report Number: 3005168196-2025-00156
• Device Sequence Number: 7892828
• Product Code: DQY
• UDI-Device Identifier: 00815948027886
• UDI-Public: 00815948027886
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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 Catalogue Number: PNS5F130SIM
• Device Lot Number: H00006745
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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
• Patient Age: 87 YR
• Patient Sex: Male