MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM FLASH ASPIRATION CATHETER; QEW

Catalog Number	LITNGFXT100H1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/14/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.The product was not returned for evaluation.Therefore, a physical device investigation was unable to be performed.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left and right pulmonary arteries (pa) using an indigo system flash aspiration catheter (flash catheter), an element vascular access sheath (element sheath), a non-penumbra pigtail catheter and a guidewire.It was reported that the patient was initially on 30 l of oxygen and was stepped down to 6 l shortly before the procedure.The patient was described as generally very sick.During the procedure, the physician accessed the pulmonary artery using a pigtail catheter.A guidewire was placed, and the element sheath was advanced into the main pulmonary artery without incident.The flash catheter was then introduced over the guidewire to access the left pulmonary artery.After removing the guidewire, aspiration was initiated, and the flash catheter was advanced distally into the left lower lobe.While preparing to proceed to the right pulmonary artery, the circulating nurse reported that the patient was coughing up blood.An angiogram was performed, revealing a perforation in the left lung.The physician attributed the perforation to the patient's diseased vessels and general poor health.Cpr was performed, and the physician deployed 11 coils in an attempt to control the bleeding; however, the patient did not regain stable hemodynamics and subsequently expired.The procedure was aborted at that point.

• Brand Name: INDIGO SYSTEM FLASH ASPIRATION CATHETER
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 24288714
• Report Number: 3005168196-2026-00044
• Device Sequence Number: 13113698
• Product Code: QEW
• UDI-Device Identifier: 00815948029866
• UDI-Public: 00815948029866
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K241399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: LITNGFXT100H1
• Device Lot Number: F00018419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female