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

Model Number PXSLIMLAN135T45

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using a lantern delivery microcatheter (lantern) and a non-penumbra catheter.It should be noted that the patient's anatomy was tortuous, narrowed, and calcified.During the procedure, the physician encountered resistance while advancing a ruby coil through the middle of the lantern.The ruby coil was then removed from the lantern and set aside and the lantern was flushed.Next, the physician attempted to advance another ruby coil through the lantern; however, resistance was encountered while advancing the ruby coil through the same position in the lantern.Therefore, the lantern containing the ruby coil was removed from the patient.The lantern was no longer used in the procedure and the ruby coil was set aside.The procedure was completed using a non-penumbra microcatheter, the same two ruby coils, nine additional ruby coils, and eight non-penumbra coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned lantern revealed a kink on the distal shaft.If the device is manipulated against resistance or is otherwise mishandled at extreme angles during use, damage such as a kink may occur.This damage may have contributed to resistance while advancing the coils during the procedure.During functional testing, a demonstration ruby coil was advanced through the lantern without an issue.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
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11975942
• MDR Text Key: 255754259
• Report Number: 3005168196-2021-01298
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 00814548016658
• Combination Product (y/n): Y
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2022
• Device Model Number: PXSLIMLAN135T45
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F95167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• 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: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR