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

Catalog Number	PXSLIMLAN150T90
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
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 left posterior tibial artery using a lantern delivery microcatheter (lantern), pod coil, non-penumbra sheath, non-penumbra catheter, and a guidewire.During the procedure, the physician obtained access in the right femoral artery using the sheath and advanced the access catheter from the right femoral artery down to the left popliteal artery.Next, the physician advanced the lantern over a guidewire into the posterior tibial artery and successfully placed a pod coil in the target location.It was reported that contrast was then injected through the lantern to confirm adequate deployment of the pod coil.Afterwards, the physician was removing the lantern and noticed that the lantern was fractured.The physician and scrub technician then noticed the fractured portion of the lantern was inside the access catheter.Therefore, the access catheter containing the fractured portion of the lantern was removed and the access catheter was flushed on the back table to remove the fractured portion of the lantern.The target vessel was successfully embolized and the procedure had ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lantern confirmed a fracture on the mid-shaft.If the device is retracted against resistance, damage such as a fracture may occur.Evaluation of the non-penumbra catheter revealed multiple kinks and ovalizations along its length.When the proximal portion of the fractured lantern was aligned with the hub of the non-penumbra catheter, the fractured location was approximately at the most proximal kinked location on the non-penumbra catheter.The kink in the non-penumbra catheter may have contributed to resistance while retracting the lantern during the procedure.Further evaluation of the returned lantern revealed kinks on the microcatheter.This damage, and the additional damages on the non-penumbra catheter were likely incidental to the complaint and may have occurred during packaging 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.H3 other text : placeholder.

• 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: 19822628
• Report Number: 3005168196-2024-00257
• Device Sequence Number: 15648719
• Product Code: DQY
• UDI-Device Identifier: 00814548016696
• UDI-Public: 00814548016696
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/12/2024
• 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: 08/13/2026
• Device Catalogue Number: PXSLIMLAN150T90
• Device Lot Number: F00007984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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: 72 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005