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

Lot Number	F00011551
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
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 an embolization procedure in the inferior mesenteric artery (ima) using a lantern delivery microcatheter (lantern) and a guidewire.It was noted that the patient's anatomy was tortuous.During the procedure, the lantern was advanced over a guidewire to the target location.When the lantern was being withdrawn from the ima, the physician experienced resistance and the distal length of the lantern fractured.A snare device was used to retrieve the fractured lantern length.The attempt was unsuccessful.The physician decided to leave the fractured lantern length in the ima.The procedure ended at this point.The patient was admitted into the hospital and was receiving frequent abdominal checks.It was reported that the patient is doing well.
Additional Manufacturer Narrative
Evaluation of the returned lantern confirmed it was fractured.Evaluation revealed a yield mark near the fracture site indicating that the lantern was likely kinked prior to fracturing.If the lantern is retracted against resistance without sufficient support, damage such as a kink and subsequent fracture may occur.Based on the reported complaint, the patient's tortuous anatomy may have contributed to resistance during retraction.Further evaluation revealed kink and bends on the catheter.The damage was incidental to the complaint.The fractured distal segment was not returned for evaluation.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: 22311964
• Report Number: 3005168196-2025-00209
• Device Sequence Number: 15656441
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: F00011551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female