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

Catalog Number PXSLIMLAN135STR

Device Problems Kinked (1339); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2016

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 number: 3005168196-2016-01510.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the left hypogastric artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced the lantern through a sheath without using a wire and then attempted to advance a pod8 coil through the lantern.While the pod8 coil was being advanced through the lantern, it stopped advancing towards the distal end of the lantern.Therefore, the physician stopped advancing the pod8 coil and removed the lantern with the coil inside.After removal of the devices, the physician visually confirmed that there was a kink at the distal end of the lantern but there was no damage to the pod8 coil.There was no alleged deficiency with the pod8 coil.However, the pod8 coil was discarded with the lantern as a new lantern was being retrieved for the procedure.Next, the physician advanced the new lantern through another manufacturer's angiographic catheter and into the target vessel.While attempting to advance a new ruby coil through the new lantern, the physician encountered friction and noticed that the lantern had accidentally backed up into the angiographic catheter and subsequently, the ruby coil began taking shape in the catheter.The physician then decided to retract the ruby coil; however, while attempting to retract the coil, the physician felt friction and the ruby coil unintentionally detached from its pusher assembly inside the angiographic catheter.Therefore, the physician removed both the ruby coil pusher assembly and the lantern.There were no damages to the lantern after removal from the patient.The physician then attempted to push the coil into the target vessel using a non-penumbra guidewire but the detached coil would not exit the angiographic catheter so the physician attempted to flush the coil out using a 20 cc syringe.However, the detached coil would still not exit the angiographic catheter.Therefore, the physician decided to pull the angiographic catheter back through the sheath and subsequently, the detached coil was able to come out with the catheter.The procedure was then successfully completed using a new lantern and a new ruby coil.There was no alleged deficiency with the second lantern.A new lantern was used to complete the procedure because the physician wanted to use a shorter length.It should be noted that the physician did not maintain a continuous flush through the rotating hemostasis valve (rhv) but did flush the lantern with a syringe in between each coil.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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6055240
• MDR Text Key: 58323558
• Report Number: 3005168196-2016-01511
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016641
• UDI-Public: 00814548016641
• 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: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/05/2019
• Device Catalogue Number: PXSLIMLAN135STR
• Device Lot Number: F69204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2016
• 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: 77 YR