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

Catalog Number	PXSLIMLAN115STR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in multiple vessels in the left hypogastric artery using a lantern delivery microcatheter (lantern), a non-penumbra select catheter and a guidewire.During the procedure, the physician successfully embolized one of the vessels using the lantern.The lantern was then removed and flushed on the back table.The physician then advanced the lantern through the select catheter to another vessel.While advancing the guidewire through the lantern, the physician noticed that the guidewire would not advance and the guidewire was outside of the lantern.Therefore, the lantern was removed.Upon removal, the guidewire was advanced again through the lantern on the back table.Subsequently, a separation was noticed on the lantern where the guidewire exited near the distal end of the lantern.Therefore, the lantern was not used for the remainder of the procedure.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 revealed that the device was fractured on its distal shaft.This damage typically occurs if the device is advanced against resistance during use.Based on the reported event, the root cause of this damage could not be determined.This damage likely contributed to the guidewire exiting the lantern before the distal tip during the procedure.The complaint reported that one of the vessels was successfully embolized using the lantern during the first pass.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 Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 17302236
• Report Number: 3005168196-2023-00331
• Device Sequence Number: 3784496
• Product Code: DQY
• UDI-Device Identifier: 00814548016610
• UDI-Public: 814548016610
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2023
• Report Date (Section F): 01/01/2005

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 Expiration Date: 02/14/2026
• Device Catalogue Number: PXSLIMLAN115STR
• Device Lot Number: F00005549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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: 75 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005