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

Catalog Number	PXSLIMLAN150T90
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure using a lantern delivery microcatheter (lantern), a select catheter, and a guidewire.During the procedure, the lantern became damaged within the select catheter.While removing the guidewire, the inner lining of the lantern was stripped out.No additional information was provided.No additional information was provided regarding the completion of the procedure.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a medical procedure using a lantern delivery microcatheter (lantern), a diagnostic catheter, and a guidewire.During the procedure, the lantern became fractured within the diagnostic catheter.While removing the guidewire, the inner lining of the lantern was stripped out.No additional information was provided.No additional information was provided regarding the completion of the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated: section b.Box 5.Describe event or problem.Evaluation of the returned lantern delivery microcatheter (lantern) revealed a fracture on the catheter shaft and the internal liner from the proximal fractured segment was pulled through the hub of the catheter.This is likely the reported damage.This type of damage such as a fracture may occur if the lantern is manipulated against resistance.Based on the reported event, the root cause of the resistance could not be determined.The liner damage may have occurred during the reported retraction of a guidewire through the damaged lantern.If the guidewire is retracted from the fractured lantern at an angle, damage such as a liner damage may occur.Further evaluation revealed kinks along the catheter.This damage was incidental to the complaint and may have occurred during packaging of the device 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: 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: 22424771
• Report Number: 3005168196-2025-00230
• Device Sequence Number: 11859326
• Product Code: DQY
• UDI-Device Identifier: 00814548016696
• UDI-Public: 00814548016696
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: PXSLIMLAN150T90
• Device Lot Number: F00010903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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 Sex: Unknown