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

Catalog Number	PXSLIMLAN150STR
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in a branch of the internal iliac artery (iia) using ruby coil lps, a lantern delivery microcatheter (lantern), an lp system detachment handle (handle), and a non-penumbra 5f catheter.During the procedure, the physician was experiencing resistance advancing the lantern through the non-penumbra catheter.Subsequently, the physician performed a fluoroscopy and noticed the lantern was broken in half into two pieces but was connected by a tiny thread.Therefore, the physician advanced a guidewire through the broken lantern and removed the lantern.A new lantern was then inserted into the target location.Next, the physician advanced a ruby coil lp into the vessel and attempted to detach it using a handle; however, the ruby coil lp failed to detach.It was also reported that the physician attempted to break the distal end of the pusher assembly to manually detach the ruby coil lp, but the coil still would not detach.Therefore, the ruby coil lp was removed.The procedure was completed using five new ruby coil lps, the same handle, lantern, and catheter.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 advanced against resistance, damage such as a kink and subsequent fracture may occur.The root cause of the resistance could not be determined.Further evaluation of the device revealed additional fractures on the proximal shaft and an ovalization on the distal shaft.This damage was likely incidental to the complaint and the root cause could not be determined.Penumbra devices are visually 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: 15700908
• Report Number: 3005168196-2022-00507
• Device Sequence Number: 6227316
• Product Code: DQY
• UDI-Device Identifier: 00814548016672
• UDI-Public: 814548016672
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/31/2022
• 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: 07/10/2025
• Device Catalogue Number: PXSLIMLAN150STR
• Device Lot Number: F00002004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• 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: 10/18/2022
• Initial Report FDA Received Date: 10/31/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005