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

Catalog Number	PXSLIMLAN135T90
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2018
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: 3005168196-2019-00132.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a lantern delivery microcatheter (lantern) and pod packing coils (podjs).During the procedure, the physician successfully placed 15 ruby coils and podjs using the lantern.The physician then felt resistance and was unable to advance the lantern further into the splenic artery past some tortuosity.Therefore, the lantern was removed, and a new lantern was successfully placed with the same non-penumbra sheath.It was reported that the tip of the lantern appeared to be bent after removal.The physician then successfully placed multiple coils.The physician then attempted to place a podj, however, the podj unintentionally detached while being advanced out of the tip of the lantern.Therefore, the physician used a snare device to remove the detached coil.The procedure ended at this point as the existing packing density was sufficient.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: 8261935
• Report Number: 3005168196-2019-00131
• Device Sequence Number: 2056770
• Product Code: DQY
• UDI-Device Identifier: 00814548016665
• UDI-Public: 00814548016665
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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): 12/21/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 08/27/2020
• Device Catalogue Number: PXSLIMLAN135T90
• Device Lot Number: F78808
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005