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

Catalog Number PXSLIMLAN115T90

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the lantern was kinked approximately 6.0 cm from the hub.Initially, the lantern was unable to be flushed.A demonstration coil was unable to be advanced past the proximal kink.A mandrel was advanced through the length of the catheter to facilitate the removal of the clot and flushing of the device.Subsequently, a demonstration coil was able to be advanced through the length of the returned lantern without issue.Conclusions: evaluation of the returned lantern revealed a kink on its proximal shaft.This kink may have been due to improper handling during preparation for use.During functional testing, a demonstration ruby coil was unable to be advanced past this proximal kink.After advancing a mandrel through the catheter to flush the device, the demonstration ruby coil was able to pass through the returned lantern without issue.Advancing the mandrel through the kink likely widened the lumen of the returned lantern resulting in the successful advancement of the demonstration ruby coil.If this kink was present during the procedure it would likely have contributed to the resistance experienced and early detachment of the embolization coils.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.This report is associated with mfr report numbers: 3005168196-2018-01157, 3005168196-2018-01158, 3005168196-2018-01159.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician felt resistance while advancing a ruby coil through the lantern and, consequently, the ruby coil unintentionally detached within the lantern.The physician therefore removed the rotating hemostatic valve (rhv) to pull out the ruby coil from the lantern.The physician then successfully placed another ruby coil.The physician then felt resistance while advancing another ruby coil within the lantern and, consequently the ruby coil unintentionally detached within the lantern.The physician again was able to remove the ruby coil by hand after removing the rhv.The physician then switched to a new lantern and successfully placed multiple ruby coils.However, the physician then felt resistance while advancing another ruby coil within its introducer sheath and into the lantern and thought that the pusher assembly was damaged, though no specific damage was noticed.The physician therefore removed the ruby coil.The procedure was completed using additional ruby coils, pod coils, and the same lantern.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: 7596690
• MDR Text Key: 111012539
• Report Number: 3005168196-2018-01160
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016634
• UDI-Public: 00814548016634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/05/2020
• Device Catalogue Number: PXSLIMLAN115T90
• Device Lot Number: F79408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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
• Patient Age: 76 YR