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

Catalog Number	PNML6F088904M
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	12/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a medical procedure to treat an arteriovenous malformation (avm) in the middle cerebral artery (mca) superior branch using a neuron max 6f 088 long sheath (neuron max), a non-penumbra sheath (8f short sheath), a non-penumbra guide catheter, and non-penumbra microcatheters.During the procedure, the physician introduced the neuron max into the internal carotid artery (ica) using the sheath.While attempting to introduce the microcatheter to the superior branch of the mca, the physician noticed clot formation.Upon further inspection, the physician found that the markerband of the neuron max had disconnected from the tip and was found in the mca, and a piece of the distal end of the neuron max had detached and migrated into the mca.The physician believed that the clot formation occurred due to the markerband detachment.The physician decided to administer heparin to treat the clot formation; however, it did not resolve.The patient then experienced an acute stroke on the operating table.It was reported that the physician believed that the stroke was caused by the damage to the neuron max.The neuron max, guide catheter, and microcatheter were then removed from the patient.The physician used another neuron max, non-penumbra microcatheter, and a stent retriever to successfully remove the detached neuron max markerband and the distal piece of the neuron max after two to three passes.The procedure was abandoned at this point.The patient is currently stable and recovering in the intensive care unit (icu).On (b)(6) 2024, it was reported that the patient was still in the icu with left side hemiparesis.
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 max confirmed that the markerband was detached and revealed significant discoloration and damage to the material on the distal end of the catheter.This type of discoloration and damage on the distal end is consistent with chemical exposure to disinfect the device for re-use.Based on the reported complaint, the root cause of this damage could not be determined, however the damage to the material on the distal end of the neuron max likely contributed to the markerband detaching from the catheter.The detached markerband was not returned for evaluation.A photograph provided confirmed that the markerband was successfully retrieved from the patient.Further evaluation revealed that the atraumatic tip was fractured.Based on the photograph provided the fracture likely occurred post procedure while packaging for return to penumbra.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: 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: 21061309
• Report Number: 3005168196-2024-00430
• Device Sequence Number: 8757893
• Product Code: DQY
• UDI-Device Identifier: 00815948022409
• UDI-Public: 00815948022409
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 02/28/2025

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: PNML6F088904M
• Device Lot Number: H00005204
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female