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

Catalog Number	PXSLIMLAN135T90
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned lantern delivery microcatheter (lantern) confirmed a fracture on the proximal end.If the lantern is advanced against resistance, damage such as a kink and subsequent fracture may occur.The reported moderately tortuous patient's anatomy may have contributed to resistance during the procedure.The proximal fractured segment of the lantern was not returned for evaluation.Further evaluation revealed multiple ovalizations on the distal end.This damage may have also occurred during advancement against resistance during the procedure.Evaluation also revealed bends along the catheter shaft.This is incidental to the reported complaint and may have occurred during packaging for return to penumbra.Penumbra devices are visually 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 was undergoing a medical procedure using a lantern delivery microcatheter (lantern) and a guidewire.It was noted that the patient's anatomy was moderately tortuous.During the procedure, after advancing the lantern into the distal target location over a guidewire, the lantern fractured at the proximal length.The lantern was removed from the patient by hand over the guide wire.The procedure was completed with a non-penumbra microcatheter.There was no report of an adverse effect to the patient.

• 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22576836
• Report Number: 3005168196-2025-00241
• Device Sequence Number: 18562350
• Product Code: DQY
• UDI-Device Identifier: 00814548016665
• UDI-Public: 00814548016665
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: PXSLIMLAN135T90
• Device Lot Number: F00013862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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: 65 YR
• Patient Sex: Male