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

Catalog Number	PXSLIMLAN150STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pulmonary arteriovenous malformation (pavm) using a pod coil, pod packing coil (packing coil), a lantern delivery microcatheter (lantern), non-penumbra sheaths, and a diagnostic catheter.During the procedure, the physician successfully placed a pod coil and packing coil in the first pavm using the lantern.Next, while advancing the lantern into the second pavm, the physician noticed the midshaft of the lantern had fractured inside the diagnostic catheter.The physician was able to remove approximately 40 centimeters of the fractured lantern out from the diagnostic catheter.The diagnostic catheter was then removed, and a gooseneck snare device was used to remove the rest of the fractured lantern out from the sheath.It was reported that the physician was unable to obtain access back into the vessel.The physician ended the procedure at this point and the patient will be brought back on a different day to complete the embolization procedure.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.If the lantern is advanced against resistance, damage such as a kink and subsequent fracture may occur.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed an additional fracture on the catheter shaft and ovalization on the distal fractured segment.This damage was incidental to the reported complaint.The ovalization and kinks on the distal fractured segment likely occurred during snaring and removal of the device from the patient¿s body.The additional fracture may have occurred during packaging of the device for return to penumbra.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.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up mfr report: 1.Section h.Box 8.Usage of device.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY, QJP
• 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: 19735771
• Report Number: 3005168196-2024-00248
• Device Sequence Number: 7006249
• Product Code: DQY
• UDI-Device Identifier: 00814548016672
• UDI-Public: 00814548016672
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 10/17/2024
• 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: 08/03/2025
• Device Catalogue Number: PXSLIMLAN150STR
• Device Lot Number: F00002477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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: 86 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005