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

Catalog Number	PXSLIMLAN135T90
Medical Device Problem Codes	Mechanical Problem (1384); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2016
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 numbers: 3005168196-2016-00682, 3005168196-2016-00683.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and lantern delivery microcatheters (lantern).During the procedure, the physician deployed and detached three soft ruby coils into the aneurysm using the lantern.While repositioning the lantern and attempting to advance a new ruby coil through it, the physician experienced resistance and decided to try and push the ruby coil through; however, the ruby coil became stuck and there was a lot of the lantern outside of the body for the pusher assembly to get kinked in.Subsequently, the ruby coil unintentionally detached within the lantern.The physician pulled the detached ruby coil out of the lantern using forceps.Next, the physician deployed and detached a new ruby coil into the patient using a new lantern.While attempting to advance another new soft ruby coil through the lantern, the physician advanced the coil with most of the lantern outside of the body causing the ruby coil pusher assembly to kink and not be as straight as needed.Therefore, the ruby coil was removed and the procedure was completed using two new soft 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: 5665290
• Report Number: 3005168196-2016-00684
• Device Sequence Number: 10769039
• Product Code: DQY
• UDI-Device Identifier: 00814548016665
• UDI-Public: 00814548016665
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/19/2016

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: 10/20/2018
• Device Catalogue Number: PXSLIMLAN135T90
• Device Lot Number: F66975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2016
• Initial Report FDA Received Date: 05/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR