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

Model Number	PXSLIMLAN150T90
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2021-00691, 3005168196-2021-00692.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ovarian vein using a lantern delivery microcatheter (lantern) and a non-penumbra diagnostic catheter.During the procedure, while inserting a lantern into the diagnostic catheter, the physician ovalized the distal tip of the lantern.However, the physician continued to insert the lantern.While advancing the lantern through the curve of the diagnostic catheter, the physician experienced resistance and subsequently, the physician kinked the lantern.Therefore, the physician removed the lantern.While advancing a new lantern without the use of a guidewire through the patient¿s tortuous anatomy into the target location, the physician experienced resistance.Subsequently, the physician kinked the distal end of the lantern.Therefore, the lantern was removed.While the physician attempted to inject contrast through a new lantern using a 5ml syringe, the syringe broke, and after forcing the injection, the lantern came out of the patient.The physician attempted to catch the lantern, but kinked the lantern mid-shaft, and the distal end of the lantern touched the floor.Therefore, the lantern was no longer used.The procedure was completed using a non-penumbra microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11620429
• Report Number: 3005168196-2021-00693
• Device Sequence Number: 3262756
• Product Code: DQY
• UDI-Device Identifier: 00814548016696
• UDI-Public: 00814548016696
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2021
• 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: 06/03/2021
• Device Model Number: PXSLIMLAN150T90
• Device Catalogue Number: PXSLIMLAN150T90
• Device Lot Number: F83804
• Was Device Available for Evaluation?: No
• 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: 03/09/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005