MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number	3MAXC
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
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 thrombectomy procedure in the left middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc), a neuron max 6f 088 long sheath (neuron max), and a guidewire.It was noted that the patient's anatomy was tortuous.During the procedure, the physician placed the neuron max in the left internal carotid artery (ica), and the guidewire was positioned distally.While advancing the 3maxc through the neuron max, the physician experienced resistance and was unable to advance the 3maxc further.The physician then decided to remove the 3maxc, and upon removal, it was noted that the distal length had become damaged.The 3maxc was no longer used for the remainder of the procedure.The procedure was completed using another 3maxc and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned penumbra system 3max reperfusion catheter (3maxc) revealed that the catheter was kinked and fractured on the mid-shaft.This is likely the reported damage on the distal length.Further evaluation revealed stress marks near the fracture.This indicates that the device was likely kinked prior to fracturing.If the 3maxc is manipulated against resistance, damage such as kinks and a subsequent fracture may occur.Based on the reported complaint, the tortuous patient¿s anatomy may have contributed to the resistance during the procedure.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: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Common Device Name: NRY
• 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: 22589962
• Report Number: 3005168196-2025-00242
• Device Sequence Number: 21114281
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 00814548019956
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160449
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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 Catalogue Number: 3MAXC
• Device Lot Number: F00013295
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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: 83 YR
• Patient Sex: Male