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

Catalog Number	PXSLIMLAN135STR
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure in the uterine artery using a lantern delivery microcatheter (lantern), a non-penumbra base catheter, and a guidewire.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician advanced the lantern through the base catheter.The lantern was then removed to reposition after losing access to the target vessel.While readvancing the lantern back into the base catheter to the target location, the physician experienced resistance.While removing the lantern, the physician noticed that the lantern was fractured at the distal end.The proximal fractured portion of the lantern was removed.The base catheter containing the remaining fractured portion of the lantern was removed and the fractured portion of the lantern was flushed out of the base catheter.No fragments of the lantern were left in the patient¿s body.The procedure was aborted.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.Further evaluation of the device revealed an ovalization on the distal shaft.If the lantern is gripped or pinched during use, damage such as an ovalization may occur.This damage may have contributed to the resistance while readvancing the lantern into the base catheter as mentioned in the complaint.If the lantern is advanced against the resistance, damage such as a kink may occur.The kink may worsen to a fracture during retraction.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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 20866321
• Report Number: 3005168196-2024-00406
• Device Sequence Number: 8564828
• Product Code: DQY
• UDI-Device Identifier: 00814548016641
• UDI-Public: 00814548016641
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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 Catalogue Number: PXSLIMLAN135STR
• Device Lot Number: F00010644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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: 28 YR
• Patient Sex: Female