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

Catalog Number	LITNGFHT100H1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Therefore, a physical device investigation was unable to be performed.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.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 pulmonary artery using an indigo system flash aspiration catheter (flash catheter), an indigo system lightning flash aspiration tubing (flash tubing), and an element vascular access sheath (element sheath).It was reported that during the procedure, the hemolock valve system was leaking; however, the physician was able to complete the procedure with the same element sheath.On 24-feb-2026, additional information was received from the clinical team that post-procedure, there was access site bleeding and an ecchymosis.Two-days post procedure, the hemoglobin dropped to 7.8 g/dl.One unit of packed red blood cells (prbcs) was given.The site remained soft without a hematoma.Acute blood loss anemia was determined by the independent medical reviewer (imr) to be a serious adverse event with a possible relationship to the indigo aspiration system and a definite relationship to the index procedure.The event is considered resolved.

• Brand Name: INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING
• 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: 24678799
• Report Number: 3005168196-2026-00093
• Device Sequence Number: 9653203
• Product Code: QEW
• UDI-Device Identifier: 00815948029880
• UDI-Public: 00815948029880
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: LITNGFHT100H1
• Device Lot Number: F00017987
• 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: 11/14/2025
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male