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

Catalog Number	PXSLIMLAN135T45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 in the right aortopulmonary collateral (apc) using a lantern delivery microcatheter (lantern), a non-penumbra catheter, and a guidewire.It was noted that the patient¿s anatomy was tortuous.During the procedure, after using the lantern and catheter for some time, the physician decided to remove the lantern to re-wire the catheter to select another collateral vessel.While removing the lantern, the physician noticed that the mid-shaft of the lantern was broken but remained connected by an inner wire.Therefore, the lantern was not used for the remainder of the procedure.The procedure was completed using a new lantern and the same catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report.1.Section b.Box 5.Describe event or problem.Evaluation of the returned lantern confirmed a fracture.If the device is manipulated against resistance, damage such as a fracture may occur.Manipulation of the lantern in the reported tortuous patient¿s anatomy may have contributed to resistance during the procedure.Further evaluation revealed kinks on the catheter and an ovalization on the distal end.The kinks were incidental to the complaint and was reported to be done after removal from the procedure.The ovalization may have occurred during manipulation of the device within the patient¿s tortuous anatomy and may have contributed to additional resistance during the procedure.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right aortopulmonary collateral (apc) using a lantern delivery microcatheter (lantern), a non-penumbra catheter, and a guidewire.It was noted that the patient¿s anatomy was tortuous.During the procedure, after using the lantern and catheter for some time, the physician decided to remove the lantern to re-wire the catheter to select another collateral vessel.While removing the lantern, the physician noticed that the mid-shaft of the lantern was broken but remained connected by an inner wire.Therefore, the lantern was not used for the remainder of the procedure.The procedure was completed using a new lantern and the same catheter.There was no report of an adverse effect to the patient.It was reported that after the procedure, the hospital fellow attempted to break the lantern in two other areas outside the patient and consequently, kinked the lantern.

• 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: 16095365
• Report Number: 3005168196-2023-00001
• Device Sequence Number: 15157705
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 814548016658
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2023
• 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: 07/31/2025
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F00002384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: 13 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005