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

Model Number	PXSLIMLAN115STR
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal iliac arteries (iia) using a lantern delivery microcatheter (lantern) and non-penumbra catheter.It was reported that the patient¿s anatomy was slightly tortuous, narrow, and mildly calcified.During the procedure, while advancing the lantern through the catheter in the target vessel, the physician encountered resistance; therefore, they were removed.The procedure was completed using another lantern and the same catheter.There was no adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned lantern was kinked at approximately 43.0 cm from the hub.The distal shaft was ovalized approximately 113.0 cm ¿ 114.0 cm from the hub.Conclusions: evaluation of the returned lantern revealed an ovalization on its distal shaft.If the lantern is forcefully gripped and pinched during the procedure, damage such as a distal ovalization may occur.During functional testing, the returned lantern was advanced through a demonstration 3maxc with resistance due to the ovalization.The distal ovalization likely contributed to the reported resistance experienced during the procedure and during the functional test.Further evaluation revealed a kink on the mid-shaft.This damage was likely incidental to the reported complaint and may have occurred during advancement of the device against resistance during the procedure.Penumbra catheters are 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.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9683587
• Report Number: 3005168196-2020-00154
• Device Sequence Number: 642896
• Product Code: DQY
• UDI-Device Identifier: 00814548016610
• UDI-Public: 00814548016610
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020
• 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: 01/02/2022
• Device Model Number: PXSLIMLAN115STR
• Device Catalogue Number: PXSLIMLAN115STR
• Device Lot Number: F87793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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