MAUDE Adverse Event Report: PENUMBRA, INC. LANTERN DELIVERY MICROCATHETER; DQY

Catalog Number	PXSLIMLAN150T45
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure using a lantern delivery microcatheter (lantern), a guide catheter, non-penumbra coils, microspheres, a contrast agent, saline, and a guidewire.During the procedure, the physician successfully implanted microspheres, two non-penumbra coils into the target vessel using the lantern.It was also reported that contrast agent and saline were also administered through the lantern.Upon removal of the lantern, the physician noticed that the lantern fractured at its distal segment.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
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 coil embolization procedure using a lantern delivery microcatheter (lantern), a guide catheter, non-penumbra coils, microspheres, a contrast agent, saline, and a guidewire.During the procedure, the physician successfully implanted microspheres, two non-penumbra coils into the target vessel using the lantern.It was also reported that contrast agent and saline were also administered through the lantern.The physician then noticed that the lantern wasn¿t performing as expected and decided to remove it.Upon removal, the physician noticed that the lantern fractured at its distal segment.The procedure was completed using a px slim delivery microcatheter (px slim).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow-up #01 mfr report 3005168196-2026-00007: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned lantern delivery microcatheter (lantern) revealed a fracture on its proximal shaft and was ovalized on the distal end.This type of damage such as ovalization on the distal end and a kink on the proximal shaft may occur if the lantern is advanced against resistance.The kink may have worsened to a fracture upon removal from the procedure.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed a kink and bend on the proximal end.This damage may have also occurred during manipulation of the lantern against 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: LANTERN DELIVERY MICROCATHETER
• 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 23995581
• Report Number: 3005168196-2026-00007
• Device Sequence Number: 13394639
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K152840
• 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): 03/22/2026

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: PXSLIMLAN150T45
• Device Lot Number: F00011330
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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: 67 YR
• Patient Sex: Female