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	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right peroneal artery using a lantern delivery microcatheter (lantern) and a glide catheter (4f).While removing the lantern from the patient, the physician observed that the lantern fractured at the midshaft within the glide catheter.The fracture was confirmed under fluoroscopy.Aspiration was applied to the glide catheter, and the glide catheter containing the fractured segment of the lantern was removed from the patient.The procedure was completed using a new lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lantern delivery microcatheter (lantern) confirmed that the catheter was fractured.If the lantern is manipulated at an angle or against resistance during use, damage such as a kink and subsequent fracture may occur.Based on the reported event, the root cause of this damage could not be determined.Penumbra devices 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 ; +1(510)748-3200
• MDR Report Key: 50475665
• Report Number: 3005168196-2026-00282
• Device Sequence Number: 13285312
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/27/2026

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: F00020895
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2026
• 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: 24 YR
• Patient Sex: Male