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

Catalog Number	PXSLIMLAN135T45
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a lantern delivery microcatheter (lantern), a ruby coil, and a coil (unknown).It should be noted that the patient's anatomy was moderately tortuous and moderately calcified.During the procedure, while attempting to advance the ruby coil through the lantern, the ruby coil became stuck within the lantern.Therefore, the ruby coil was removed.The physician then attempted to advance a new coil through the lantern; however, it became stuck in the same location and could not be advanced further.Therefore, the lantern and the coil were removed.Upon removal, the lantern was found to be broken.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 in the internal iliac artery (iia) using a lantern delivery microcatheter (lantern), a ruby coil, and a coil (unknown).It should be noted that the patient's anatomy was moderately tortuous and moderately calcified.During the procedure, while attempting to advance the ruby coil through the lantern, the ruby coil became stuck within the lantern.Therefore, the ruby coil was removed.The physician then attempted to advance a new coil through the lantern; however, it became stuck in the same location and could not be advanced further.Therefore, the lantern and the coil were removed.Upon removal, it was found that the proximal length of the lantern was fractured and the fractured piece was removed by hand.The procedure was completed using a new lantern and the same angiographic catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the distributor on 09/18/2025: section b.Box 5.Describe event or problem.Evaluation of the returned lantern delivery microcatheter (lantern) confirmed that the catheter was fractured.If the lantern is retracted against resistance, damage such as a fracture may occur.Based on the reported event, the root cause of the resistance could not be determined.Further evaluation revealed a kink and ovalization along the catheter shaft.This damage was incidental to the reported complaint; however, the kink may have contributed to the ruby coil becoming stuck within the lantern during advancement.The root cause of the ovalization 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.Note: based on the additional information provided by the distributor on 09/18/2025, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.

• 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: 23069466
• Report Number: 3005168196-2025-00300
• Device Sequence Number: 21343299
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 00814548016658
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: PXSLIMLAN135T45
• Device Lot Number: F00014644
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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