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

Catalog Number	PNML6F088904
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Brain Injury (2219); Foreign Body Embolism (4439)
Date of Event	03/21/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 thrombectomy procedure using a neuron max 6f 088 long sheath (neuron max).With some difficulty, the neuron max was advanced through a stent at the origin of the left common carotid artery.Upon removal of the neuron max 6f select inner catheter, the neuron max distal tip was found to be fractured.Contrast injection demonstrated minimal flow into the left middle cerebral artery as well as the left anterior cerebral artery due to the fractured neuron max segment.Attempts to retrieve the neuron max fractured segment were unsuccessful followed by gross subarachnoid hemorrhage.Subsequent coil occlusion of the left internal carotid artery was performed to control bleeding.The physician ended the procedure at this point.Post-procedure, the patient remained intubated, not sedated, requiring four vasopressors.The patient had no cough, gag, or corneal reflex.Pupils were 7mm and nonreactive bilaterally.Discussion with the spouse/family given hemodynamic instability and unlikely meaningful outcome.The family decided to transition to comfort care, and the patient expired on (b)(6) 2025.

• 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: 21869144
• Report Number: 3005168196-2025-00126
• Device Sequence Number: 7841835
• Product Code: DQY
• UDI-Device Identifier: 00815948022393
• UDI-Public: 00815948022393
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PNML6F088904
• Device Lot Number: H00006653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 50 KG