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

Catalog Number	PXSLIMLAN150T45
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left ovarian vein using a lantern delivery microcatheter (lantern), pod coils, and a diagnostic guide catheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician experienced resistance while advancing a pod coil through the lantern.The physician then successfully implanted the pod coil into the target vessel.While retracting the pusher assembly of the pod coil, it fractured within the lantern and only a part of the pusher assembly was removed.Without realizing that part of the pod coil pusher assembly was fractured inside the lantern, the physician attempted to advance a pod packing coil (pod pc) through the lantern.However, resistance was encountered, and the physician removed the pod pc and the lantern to check the system.Upon removal, the physician found that the lantern was fractured at the distal end.Therefore, the lantern was no longer used in the procedure.The procedure was completed using a new lantern to implant the same pod pc and an additional pod pc, and the same diagnostic guide catheter.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Evaluation of the returned lantern could not confirm the distal fracture.Evaluation revealed multiple kinks and fractures along the proximal and midshaft.This damage is likely the reported fracture.If the device is manipulated against resistance during use, damage such as kinks and subsequent fractures may occur.The reported tortuous patient¿s anatomy may have contributed to resistance.Some of the observed kinks may have been incidental and likely 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.

• 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: 17726343
• Report Number: 3005168196-2023-00424
• Device Sequence Number: 17742380
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 814548016689
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023
• 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: 06/08/2026
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F00007104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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: 37 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005