MAUDE Adverse Event Report: PENUMBRA, INC. NEURON SELECT CATHETER 6F; DQY

Catalog Number	BMX9680BER105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
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 a medical procedure in the carotid artery using a benchmark bmx96 access system (bmx96) and a neuron select catheter 6f (6f select).During the procedure, while advancing the 6f select catheter in the carotid artery, the physician noticed the distal length of the 6f select had fractured in the femoral artery under fluoroscopy.Therefore, the physician removed the proximal portion of the 6f select out from the bmx96.The physician then advanced the bmx96 from the right femoral artery to the left femoral artery and used a snare device to successfully remove the fractured 6f select.The physician decided to end the procedure and is rescheduled for a later date.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up mfr report: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned neuron select catheter 6f (6f select) confirmed that the catheter was fractured.This type of damage typically occurs if the device is advanced against resistance, the 6f select may kink and subsequently fracture.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation revealed an additional fracture.This damage was incidental to the reported complaint and likely occurred during snaring of the device.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.
Event or Problem Description
The patient was undergoing a medical procedure in the carotid artery using a benchmark bmx96 access system (bmx96) and a neuron select catheter 6f (6f select).During the procedure, while advancing the 6f select catheter in the carotid artery, the physician noticed under fluoroscopy that the distal length of the 6f select had fractured and traveled to the femoral artery.Therefore, the physician removed the proximal portion of the 6f select out from the bmx96.The physician then advanced the bmx96 from the right femoral artery to the left femoral artery and used a snare device to successfully remove the fractured 6f select.The physician decided to end the procedure and is rescheduled for a later date.There was no report of an adverse effect to the patient.

• Brand Name: NEURON SELECT CATHETER 6F
• 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: 21437083
• Report Number: 3005168196-2025-00044
• Device Sequence Number: 4605793
• Product Code: DQY
• UDI-Device Identifier: 00815948022638
• UDI-Public: 00815948022638
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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): 04/11/2025

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: 12/29/2025
• Device Catalogue Number: BMX9680BER105
• Device Lot Number: H00001802
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2022
• 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: 65 YR
• Patient Sex: Female