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

Catalog Number PXSLIMLAN150T45

Device Problems Collapse (1099); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a lantern delivery microcatheter (lantern).During the procedure, the lantern was flushed and advanced to the target vessel.The physician then found that the lantern had become flattened and the guidewire was not able to advance through.The lantern was reported to be collapsed at approximately the middle to proximal end, and was therefore removed from the procedure.The procedure was completed using a new lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the lantern was ovalized and had multiple consecutive kinks from approximately 144.5 ¿ 149.5 cm from the hub.During functional testing, resistance was experienced at the ovalization while advancing a 0.025¿ stainless steel mandrel through the lantern and the mandrel could not advance any further.Conclusions: evaluation of the returned lantern revealed distal ovalizations and consecutive kinks.If the peel away sheath included with the lantern is not properly utilized when advancing the lantern into parent device, damage such as distal ovalizations and consecutive kinks may occur.This damage likely contributed to the reported complaint.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.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8527262
• MDR Text Key: 142359632
• Report Number: 3005168196-2019-00741
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• Combination Product (y/n): Y
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2021
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F85361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR