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

Catalog Number PXSLIMLAN150T45

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.The reported complaint involves the sterility of a dropped device prior to use in the patient.Sterility of a dropped device cannot be confirmed in the evaluation lab and does not involve manufacturing records; therefore, an investigation will not be performed.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery.While preparing to use a lantern delivery microcatheter (lantern), the lantern was accidentally dropped on the floor and became unsterile.The lantern was dropped prior to use and therefore not used in the procedure.The procedure was completed using a another microcatheter.

• 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: 8589100
• MDR Text Key: 144691421
• Report Number: 3005168196-2019-00895
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2021
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F85952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 04/08/2019
• Date Device Manufactured: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1