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

Catalog Number PXSLIMLAN115T45

Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2017

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: 3005168196-2017-00424, 3005168196-2017-00425.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern).During preparation for the procedure, the lantern became kinked upon removal from its packaging.Therefore, the lantern did not enter the patient's body and was not used for the procedure.A new lantern was then opened and used for the procedure.During the procedure, the physician partially advanced two ruby coils out of the lantern and into the patient but then decided to retract and resheath both coils in order to reposition the lantern.Upon attempting to re-deploy both ruby coils, the physician was unable to advance both coils out of the lantern and into the patient.Therefore, both ruby coils were removed and the procedure was completed using the same lantern and new ruby coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that (b)(4) were incorrectly entered on the initial mfr report and that (b)(4) should have been entered but was not and is being reported on this follow-up #1 mfr report.

• 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: 6425715
• MDR Text Key: 70631951
• Report Number: 3005168196-2017-00426
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016627
• UDI-Public: 00814548016627
• 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,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2019
• Device Catalogue Number: PXSLIMLAN115T45
• Device Lot Number: F70252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2016
• 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