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

Catalog Number	PXSLIMLAN150T90
Medical Device Problem Codes	Break (1069); Material Perforation (2205); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/21/2019
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
During preparation for a medical procedure using a lantern delivery microcatheter (lantern), while placing the lantern over a non-penumbra guidewire, the physician experienced resistance and the guidewire was found to have perforated through the lantern; consequently, the lantern had broken in half.The damage to the lantern occurred prior to use and prior to inserting it into the patient¿s body; therefore, it was not used in the procedure.The procedure was completed using a new lantern with the same guidewire.
Additional Manufacturer Narrative
Results: the lantern was fractured approximately 99.5 cm from the hub.The fractured distal segment of the lantern was ovalized approximately 147.0 and 149.0 cm from the hub and had coagulated blood inside the lumen.Conclusions: evaluation of the returned lantern revealed that the catheter was fractured.If the lantern is forcefully handled during preparation or use at an extreme angle, damage such as a guide wire perforating through the catheter and fracturing the device may occur.Further evaluation of the returned lantern revealed that the distal segment was ovalized and had coagulated blood inside the lumen.Based on the reported complaint and return condition, the ovalizations were likely incidental to the reported complaint.The root cause of the coagulated blood inside the lumen could not be determined.The complaint states that the damage to the lantern occurred prior to use and insertion into the patient¿s body and, therefore, it was not used in the procedure.The non-penumbra guide wire identified in the complaint was not returned for evaluation.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.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8445147
• Report Number: 3005168196-2019-00535
• Device Sequence Number: 429029
• Product Code: DQY
• UDI-Device Identifier: 00814548016696
• UDI-Public: 00814548016696
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 02/21/2019
• 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: 06/03/2021
• Device Catalogue Number: PXSLIMLAN150T90
• Device Lot Number: F83804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/07/2019
• 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