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

Catalog Number	PXSLIMLAN150T45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an arteriovenous malformation (avm) using a lantern delivery microcatheter (lantern) and a non-penumbra microcatheter.During the procedure, the physician advanced the non-penumbra microcatheter into the desired location.Next, the physician removed the microcatheter and switched to a lantern.While advancing the lantern to the target location, the physician noticed the radiopaque marker of the lantern was not moving.Therefore, the physician injected contrast through the lantern and noticed contrast was exiting around the middle of the lantern.Subsequently, the lantern had broken into two separates pieces in the avm.Therefore, the physician used a snare device to remove the broken end of the lantern.The procedure was completed using a new microcatheter and ruby coils.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 at an extreme angle during use, damage such as a kink may occur.Further manipulation of a kinked device may worsen to a fracture.Evaluation also revealed ovalization and a kink on the distal shaft.This damage was incidental to the reported complaint and may have of occurred during snaring of the device upon removal from the patient.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: 15482076
• Report Number: 3005168196-2022-00450
• Device Sequence Number: 1919345
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 814548016689
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 10/05/2022
• 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: 02/22/2025
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F113123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 09/25/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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: 47 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005