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

Catalog Number	PXSLIMLAN135T90
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.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: 3005168196-2016-00943.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a ruby coil into the lantern but was unable to advance the coil out of the tip of the lantern.Therefore, the physician retracted the ruby coil; however, while the coil was being retracted, it unintentionally detached within the lantern.The lantern was pulled out of the patient and the coil was flushed out of it on the back table.Next, the physician reintroduced the lantern into the patient and attempted to advance a second ruby coil through it.This second ruby coil also advanced through the lantern but was unable to advance out of the tip of the lantern.Therefore, the coil was retracted and resheathed and a second lantern was opened.Thereafter, the physician attempted to advance the same ruby coil that was resheathed through the new lantern and was able to deploy and detach this coil into the aneurysm.The procedure was then successfully completed using a total of twelve ruby coils and the second lantern.There was no report of an adverse effect to the patient.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5772624
• Report Number: 3005168196-2016-00942
• Device Sequence Number: 13512435
• Product Code: DQY
• UDI-Device Identifier: 00814548016665
• UDI-Public: 00814548016665
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2016

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: Physician
• Device Expiration Date: 12/10/2018
• Device Catalogue Number: PXSLIMLAN135T90
• Device Lot Number: F66890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2016
• Initial Report FDA Received Date: 07/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR