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

Catalog Number	PXSLIMLAN135T90
Medical Device Problem Codes	Fracture (1260); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the lantern was fractured just proximal to its first marker band approximately 133.0 cm from the hub.Conclusions: evaluation of the returned lantern revealed a fracture on its distal tip.This damage may have been a result of forceful mishandling when removing the shaping mandrel from the distal tip of the lantern.The shaping mandrel and packaging hoop were not returned for evaluation.The root cause of the reported fracture could not be determined.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a coil embolization procedure, the hospital staff found that the clear lining of the lantern delivery microcatheter (lantern) had broken and came forward past the radio-opaque tip and there was no shape to the end of the catheter upon removal from the packaging.The damage to the lantern was found prior to use.Therefore, the lantern was not used in the procedure.The procedure was completed using additional microcatheter.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7535081
• Report Number: 3005168196-2018-01039
• Device Sequence Number: 13840520
• Product Code: DQY
• UDI-Device Identifier: 00814548016665
• UDI-Public: 00814548016665
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/28/2018

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: 09/12/2020
• Device Catalogue Number: PXSLIMLAN135T90
• Device Lot Number: F79504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1