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

Catalog Number	LITNGFHT115BER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reperfusion Injury (4851)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a thrombectomy procedure to treat mixed acute, subacute, chronic pulmonary embolism (pe) on (b)(6) 2025 using an indigo system flash aspiration catheter (flash catheter), a neuron select catheter 6f (6f select), an indigo system separator 12 ((b)(6)), a penumbra engine (engine), and a guidewire.In the immediate postoperative period, the patient presented with respiratory decompensation and massive hemoptysis requiring orotracheal intubation and mechanical ventilation.It was reported this was likely due to a reperfusion injury.The patient was reported to be hemodynamically stable without vasopressor use and was placed on fio2 100% with o2 sats of 94% and transferred back to the intensive care unit (icu).On (b)(6) 2025, the event was considered resolved.The patient was extubated with gradual increase of oxygen requirements.The patient was also started on a blood thinner (clexane, enoxaparin sodium).On (b)(6) 2025, the patient was transitioned to another blood thinner (marevan, warfarin sodium) while continuing clexane as a bridge.The patient was discharged home on (b)(6) 2025 with slight dyspnea.The patient missed the 90-day follow-up appointment.The reperfusion injury was determined by the independent medical reviewer (imr) to be a serious adverse event with a definite relationship to both the flash catheter and the index procedure.
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.

• 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: 24607529
• Report Number: 3005168196-2026-00079
• Device Sequence Number: 13345853
• Product Code: QEW
• UDI-Device Identifier: 00815948029453
• UDI-Public: 00815948029453
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K240030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: LITNGFHT115BER
• Device Lot Number: F00011013
• 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: 02/19/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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: 31 YR
• Patient Sex: Male