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

Catalog Number	LITNGFHT100BER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right pulmonary artery (pa) using an indigo system flash aspiration catheter (flash catheter), an indigo system lightning flash aspiration tubing (flash tubing), a non-penumbra selection catheter, a non-penumbra catheter, and a guidewire.Towards the end of the procedure, a pulmonary hemorrhage in the right middle lobe was identified.As a result of the hemorrhage, blood was present in the airway, necessitating rapid sequence induction (rsi) and endotracheal tube (ett) intubation.The patient subsequently experienced hemodynamic collapse, and cardiopulmonary resuscitation (cpr) was initiated, with return of spontaneous circulation (rosc).Following bronchoscopy and echocardiographic evaluation, the procedure was abandoned, and all devices were removed from the patient.There was no reported issue with the flash catheter or the flash tubing during the procedure.It was reported that the patient received inotropes (adrenaline, noradrenaline, vasopressin, milrinone), 1 unit of blood, 1 bottle of albumin, and 2.5 liters of intravenous (iv) fluids.An additional medical procedure was also performed to treat the patient.The patient was then transferred back to the intensive care unit (icu).As of (b)(6) 2026, the patient remains intubated in the icu.There is no further bleeding, and inotrope requirements are decreasing.On (b)(6) 2026, it was reported that the patient is still recovering in the hospital but is no longer in the icu.The pulmonary hemorrhage was reported as a serious adverse event with a possible relationship to the indigo aspiration system (flash catheter) and a definite relationship to 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: 24434217
• Report Number: 3005168196-2026-00056
• Device Sequence Number: 18740210
• Product Code: QEW
• UDI-Device Identifier: 00815948029446
• UDI-Public: 00815948029446
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: LITNGFHT100BER
• Device Lot Number: F00015471
• 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: 01/28/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female