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

Catalog Number	PXSLIMLAN135T90
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2017
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: 3005168196-2017-00193.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pelvis congestion using a lantern delivery microcatheter (lantern) and ruby coils.During the procedure, while attempting to advance a lantern through a non-penumbra 5f diagnostic catheter, the physician experienced resistance and subsequently, the lantern became stuck.Therefore, the physician removed the lantern and swapped out the diagnostic catheter for another non-penumbra 5f diagnostic catheter.The physician then advanced a non-penumbra microcatheter through the diagnostic catheter and attempted to advance a new ruby coil through the microcatheter.While attempting to advance the ruby coil through the microcatheter, the physician did not mention feeling any resistance but subsequently kinked the ruby coil pusher assembly.Therefore, the ruby coil was removed and the procedure was completed using additional ruby coils, pod coils, pod packing coils and the same microcatheter.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: 6329348
• Report Number: 3005168196-2017-00192
• Device Sequence Number: 16312098
• Product Code: DQY
• UDI-Device Identifier: 00814548016665
• UDI-Public: 00814548016665
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2017

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: Physician
• Device Expiration Date: 10/13/2018
• Device Catalogue Number: PXSLIMLAN135T90
• Device Lot Number: F66723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2017
• Initial Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR