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

Catalog Number	PXSLIMLAN115STR
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
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: 3005168196-2019-01976.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right and left ovarian veins using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician was able to successfully implant four ruby coils into the right ovarian vein using the lantern and a non-penumbra sheath.The physician then advanced the devices into the left ovarian vein.It was reported that accessing this vessel was challenging.However, the physician was able to successfully implant two ruby coils into the left ovarian vein.Upon advancement of the next ruby coil halfway out of the lantern and into the patient's vessel, the coil unintentionally detached.Therefore, the lantern and ruby coil were removed from the patient by hand.Upon removal of the lantern, the physician noticed a small kink between the two markers on the distal end.Another lantern was then opened and used to complete the procedure.While the technician was preparing two additional ruby coils for use, the ruby coils became kinked upon removal from their packaging hoops.Therefore, the ruby coils were not used in the procedure.The procedure was completed using two additional ruby coils.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: 9219622
• Report Number: 3005168196-2019-01977
• Device Sequence Number: 2183509
• Product Code: DQY
• UDI-Device Identifier: 00814548016610
• UDI-Public: 00814548016610
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 09/24/2019
• 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: 04/16/2022
• Device Catalogue Number: PXSLIMLAN115STR
• Device Lot Number: F89657
• 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: 09/24/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005