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

Catalog Number	PXSLIMLAN135T45
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
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 internal iliac artery (ica) using a lantern delivery microcatheter (lantern), and a non-penumbra catheter.It was noted that the patient¿s anatomy was moderately tortuous.During the procedure, while advancing the lantern into the patient, the physician experienced resistance, but was able to advance the lantern into the target vessel.The physician then advanced the ruby coil through the lantern; however, resistance was encountered.Therefore, the lantern containing the ruby coil was removed from the patient.After removal, the physician found that the distal end of the lantern was fractured but remained connected by the inner wire.The procedure was completed using a new lantern, the previously removed ruby coil, and pod packing coils (pod pc).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 against resistance, damage such as a kink and subsequent fracture may occur.Based on the reported complaint, the patient anatomy was tortuous and may have contributed to resistance during the procedure.Further evaluation revealed an additional fracture on the catheter shaft near the hub.This damage was incidental to the reported complaint and the root cause could not be determined.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: 17430742
• Report Number: 3005168196-2023-00365
• Device Sequence Number: 2709669
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 814548016658
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/10/2023
• 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: 05/19/2025
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F00000883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2022
• 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