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

Catalog Number	PXSLIMLAN150STR
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a lantern delivery microcatheter (lantern), neuron select catheter 5f (5f select), pod packing coil (pod pc), and non-penumbra coils.During the procedure, the physician experienced resistance advancing a guidewire through the lantern and into the target vessel.It was reported the physician may have punctured the lantern with the guidewire.Next, the physician removed the guidewire and attempted to advance a pod pc and other coils through the lantern, but the coils would not advance.Therefore, the physician decided to remove the lantern.Subsequently, the physician had difficulty removing the lantern and upon removal, the physician bent and broke 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 non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lantern confirmed that the catheter was fractured.Based on the reported event, this damage likely occurred during removal of the device.If the lantern is retracted at an angle during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed ovalization on the distal fractured segment.This damage was incidental to the reported complaint.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.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2023-00103.1.Section h.Box 4.Device manufacture date.

• 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: 16559043
• Report Number: 3005168196-2023-00103
• Device Sequence Number: 5497710
• Product Code: DQY
• UDI-Device Identifier: 00814548016672
• UDI-Public: 814548016672
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 06/27/2023
• 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: 07/10/2025
• Device Catalogue Number: PXSLIMLAN150STR
• Device Lot Number: F00002004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 03/09/2023; 01/14/2005
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 03/22/2023; 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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: 65 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005