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

Catalog Number PXSLIMLAN115T45

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the lantern was ovalized approximately 112.0 cm from the hub to the distal tip.Conclusions: evaluation of the returned device revealed that the distal tip of the lantern was ovalized.This type of damage typically occurs due to improper handling during use.If the distal tip of the catheter is forcefully gripped or pinched during insertion, damage such as this may occur.The ovalized distal tip of the lantern likely contributed to the reported resistance and prevented the lantern from being advanced into the non-penumbra catheter.The non-penumbra catheter referred to in the complaint was not returned to penumbra for evaluation.Penumbra catheters are visually 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.

Event Description

The patient was undergoing a coil embolization procedure using a lantern delivery microcatheter (lantern).During the procedure, the physician was opened and flushed the lantern, and then attempted to advance the lantern into the non-penumbra catheter using a guidewire.However, the physician felt resistance and was unable to advance the lantern into the hub of the catheter, despite attempting twice.The lantern was therefore removed, and the procedure was completed using a new lantern.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: 7444835
• MDR Text Key: 106040678
• Report Number: 3005168196-2018-00811
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016627
• UDI-Public: 00814548016627
• 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: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/10/2020
• Device Catalogue Number: PXSLIMLAN115T45
• Device Lot Number: F78659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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