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

Catalog Number	PXSLIMLAN150STR
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
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 in the inferior mesenteric artery (ima) using a lantern delivery microcatheter (lantern), a non-penumbra sheath and a non-penumbra catheter.It was reported that the patient¿s anatomy was tortuous.During the procedure, the lantern was advanced to the target location.Next, contrast was injected and it was noticed that the contrast was leaking from the distal part of the lantern and the lantern was fractured.Therefore, the lantern was pulled out of the catheter and was not used for the remainder of the procedure.The procedure was completed using a new lantern, the same sheath and the same catheter.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a medical procedure in the inferior mesenteric artery (ima) using a lantern delivery microcatheter (lantern), a non-penumbra sheath and a non-penumbra catheter (0.035).It was reported that the patient¿s anatomy was tortuous.During the procedure, the lantern was advanced to the target location.Next, contrast was injected and it was noticed that the contrast was leaking from the lantern and the lantern was fractured.Therefore, the lantern was pulled out of the catheter and was not used for the remainder of the procedure.The procedure was completed using a new lantern, the same sheath and the same catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated: 1.Section b.Box 5.Describe event or problem evaluation of the returned lantern delivery microcatheter (lantern) confirmed fracture on the mid shaft.If the lantern is advanced against resistance, damage such as a kink and subsequent fracture may occur.This damage likely contributed to the reported contrast leak during the procedure.Based on the reported complaint, the patient¿s tortuous anatomy may have contributed to the resistance.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: 21612777
• Report Number: 3005168196-2025-00082
• Device Sequence Number: 7756838
• Product Code: DQY
• UDI-Device Identifier: 00814548016672
• UDI-Public: 00814548016672
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 04/09/2025

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: PXSLIMLAN150STR
• Device Lot Number: F00013991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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: 71 YR
• Patient Sex: Male