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

Model Number PXSLIMLAN135STR

Device Problems Material Puncture/Hole (1504); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-01162.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery using a lantern delivery microcatheter (lantern), pod coils, and a 5f non-penumbra catheter.During the procedure, the physician advanced the lantern to the target vessel using the non-penumbra catheter.While advancing a pod coil through the lantern, the physician experienced resistance, and subsequently, the pod coil became stuck in the mid-shaft of the lantern.Therefore, the pod coil and the lantern were removed.Upon inspection on the back table, the physician noticed a kink and a perforation on the lantern approximately 90 cm from the distal tip.The physician then inserted a new lantern into the target location.While re-advancing the previously removed pod coil through the lantern, the physician experienced resistance, and subsequently, the pod coil became stuck.Therefore, the pod coil was removed.The procedure was completed using another pod coil, five ruby coils, the second lantern, and the same non-penumbra catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned lantern revealed a mid-shaft fracture.If the device is forcefully mishandled at an extreme angle during advancement, damage such as a kink may occur.Further manipulation of the kinked device may result in the device fracture.This damage likely contributed to the resistance experienced while advancing the pod8 through the lantern during the procedure.Further evaluation of the device revealed an ovalization in the distal shaft.Based on the reported complaint, this damage was likely incidental to the complaint.Evaluation of the returned pod8 revealed a functional device.During functional testing, the device was able to advance through a demonstration lantern without issue.Further evaluation of the device revealed a pusher assembly kink.This damage was likely incidental to the complaint.Penumbra coils and 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.This report is associated with mfr report number: 3005168196-2021-01162.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11882177
• MDR Text Key: 255148351
• Report Number: 3005168196-2021-01161
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016641
• UDI-Public: 00814548016641
• 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: 01/01/2005,05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2023
• Device Model Number: PXSLIMLAN135STR
• Device Catalogue Number: PXSLIMLAN135STR
• Device Lot Number: F102591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• 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: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1