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	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using a lantern delivery microcatheter (lantern), a guidewire and coils.During the procedure, the physician successfully placed coils in the target location using the lantern.While retracting and re-advancing the lantern within the rotating hemostasis valve (rhv), the physician experienced resistance.Subsequently, after removal of the lantern, the physician noticed that the mid-shaft of the lantern was fractured.It was reported that the rhv was overtightened at the location of the fracture.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text: placeholder.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 06/28/2023: 1.Section b.Box 5.Describe event or problem h3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using a lantern delivery microcatheter (lantern), a guidewire and coils.During the procedure, the physician successfully placed coils in the target location using the lantern.While retracting and re-advancing the lantern within the rotating hemostasis valve (rhv), the physician experienced resistance.Next, the physician injected contrast using a reinforced 3cc syringe to check if the vessel was occluded, and noticed the contrast coming out of the lantern hub.After removing the lantern, the physician noticed that the mid-shaft of the lantern was fractured.It was reported that the rhv was overtightened at the location of the fracture.The procedure was completed using a new lantern and additional coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lantern confirmed a fracture.It was reported that the fracture occurred at the rotating hemostasis valve (rhv) and the rhv was overtightened.The rhv being overtightened likely contributed to resistance experienced during the procedure.If the device is manipulated against resistance, damage such as a fracture may occur.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: 17186477
• Report Number: 3005168196-2023-00293
• Device Sequence Number: 15050686
• 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,Followup
• Report Date (Section B): 08/23/2023
• 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: 12/08/2025
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F00004590
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 08/09/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/29/2023; 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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: Male
• Date Report Sent to FDA: 01/01/2005