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

Catalog Number	PXSLIMLAN115T90
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for the procedure, while removing the metal memory stylet from the distal tip of the lantern delivery microcatheter (lantern) , the operating room technologist noticed that the distal portion of the lantern broke off with the metal stylet.The lantern broke prior to use and therefore, was not used in the procedure.The procedure was successfully completed using a new lantern.
Additional Manufacturer Narrative
Results: the lantern was fractured approximately 113.0 cm from the hub.There were no abnormalities or damage on the packaging mandrel.The outer diameter (od) of the packaging mandrel was measured and found to be within specification.Conclusions: evaluation of the returned device confirmed the distal end of the lantern was fractured.This damage may have occurred due to forceful handling of the lantern during removal from the packaging or preparation for use.If the distal shaft of the lantern is forcefully gripped or otherwise forcefully handled while the packaging mandrel is withdrawn from the lantern, damage such as this may occur.There were no abnormalities or damage on the packaging mandrel.The od of the packaging mandrel was measured and found to be within specification.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
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6425966
• Report Number: 3005168196-2017-00437
• Device Sequence Number: 16278974
• Product Code: DQY
• UDI-Device Identifier: 00814548016634
• UDI-Public: 00814548016634
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2017

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
• Operator of Device: Radiologic Technologist
• Device Expiration Date: 01/21/2019
• Device Catalogue Number: PXSLIMLAN115T90
• Device Lot Number: F67549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1