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

Model Number	PXSLIMLAN150T90
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure using a lantern delivery microcatheter (lantern) and a rotating hemostasis valve (rhv).During the procedure, the physician was unable to advance the lantern into the opened rhv and, consequently, kinked the lantern at multiple locations towards the distal end.Therefore, the lantern was removed.The procedure was completed using a new lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lantern confirmed multiple kinks on the distal shaft and revealed an ovalization on the distal tip.If the peel-able sheath (supplied by penumbra) is not properly used to protect the distal shaft of the lantern during insertion into a parent device, and the lantern is forcefully gripped or pinched, damage such as an ovalization may occur.This ovalization likely contributed to the difficulty advancing the lantern through the rhv during the procedure.Forceful advancing the device through the rhv likely resulted in the kinks on the distal shaft.During functional testing, the lantern was unable to advance through a demonstration rhv and benchmark due to the ovalization on the distal tip.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: 12933749
• Report Number: 3005168196-2021-02752
• Device Sequence Number: 17370016
• Product Code: DQY
• UDI-Device Identifier: 00814548016696
• UDI-Public: 00814548016696
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2021
• 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: 03/28/2024
• Device Model Number: PXSLIMLAN150T90
• Device Catalogue Number: PXSLIMLAN150T90
• Device Lot Number: F104934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• 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: 11/08/2021
• Initial Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• 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