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

Model Number PXSLIMLAN135T45

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2021

Event Type  malfunction  

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: 3005168196-2021-00692, 3005168196-2021-00693.

Event 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
• Type of Device: 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: 11620387
• MDR Text Key: 244025868
• Report Number: 3005168196-2021-00691
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 00814548016658
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: PXSLIMLAN135T45
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F101883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1