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

Catalog Number PXSLIMLAN135T45

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

The product was disposed of by the hospital and is no longer available for return.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: 3005168196-2018-00955.

Event Description

The patient was undergoing a coil embolization procedure using a lantern delivery microcatheter (lantern) and penumbra coil 400s (pc400s).During the procedure, the physician successfully placed the lantern in the target location and then attempted to advance a pc400 through it.The physician, however; experienced resistance around the tip of the coil reaching the tip of the lantern and was unable to advance the pc400 through the lantern, and therefore the lantern was removed with the pc400 inside.The procedure was then completed using a new microcatheter, the same pc400, additional pc400s, and additional coils.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: 7492265
• MDR Text Key: 107565235
• Report Number: 3005168196-2018-00954
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 00814548016658
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/27/2020
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F79735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2017
• 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