MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Catalog Number	PNML6F088904M
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
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 underwent a medical procedure in the vertebral artery using a neuron max 6f 088 long sheath (neuron max) and a guidewire.During the procedure, the physician experienced resistance while advancing the guidewire through the distal length of the neuron max.After completing the procedure, the physician retracted the neuron max out of the patient and found that it was damaged at the distal end.At this point, the procedure was already completed and no additional devices were required.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated: section b.Box 5.Describe event or problem.Evaluation of the returned neuron max 6f 088 long sheath (neuron max) confirmed that the catheter was damaged on the distal end and revealed a fracture.This type of damage typically occurs during removal from the packaging.If the packaging mandrel becomes loose from the packaging card, the distal tip may become pinned between the packaging mandrel and the packaging tube.Retraction of the device after becoming pinned will likely result in this damage and is likely what caused the damage noticed at the end of the procedure.The packaging card and mandrel were not returned for evaluation.Based on the reported complaint and the returned packaging condition, the root cause of this damage could not be determined.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 underwent a medical procedure in the vertebral artery using a neuron max 6f 088 long sheath (neuron max) and a guidewire.During the procedure, the physician experienced resistance while advancing the guidewire through the distal length of the neuron max.After completing the procedure, the physician retracted the neuron max out of the patient and found that it was fractured at the distal end.At this point, the procedure was already completed and no additional devices were required.There was no report of an adverse effect to the patient.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• 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: 22128419
• Report Number: 3005168196-2025-00186
• Device Sequence Number: 12623921
• Product Code: DQY
• UDI-Device Identifier: 00815948022409
• UDI-Public: 00815948022409
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K111380
• 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): 07/23/2025

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: PNML6F088904M
• Device Lot Number: H00005490
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: 56 YR
• Patient Sex: Male