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

Catalog Number PXSLIMLAN150T90

Device Problems Break (1069); Material Perforation (2205); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2019

Event Type  malfunction  

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 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.

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
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8445147
• MDR Text Key: 139601904
• Report Number: 3005168196-2019-00535
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016696
• UDI-Public: 00814548016696
• Combination Product (y/n): Y
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1