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	02/15/2026
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 left and right lungs using an indigo system flash aspiration catheter (flash catheter), an element vascular access sheath (element), a non-penumbra catheter, a non-penumbra sheath, guidewire, and a micro access kit.After successfully treating the right lobe using the flash catheter, the guidewire and the flash catheter were advanced into the left pulmonary artery.Two successful passes were completed using the flash catheter in the left lower lobe.The guidewire was first advanced into the sub-segmental branch of the lower left lobe and the flash catheter was then advanced over the guidewire toward the branch.The guidewire was retracted into the flash catheter to perform a contrast injection.It was reported that the patient started to cough up blood.The contrast injection revealed contrast staining on the sub-segmental branch of the lower left lobe.The flash catheter was removed.A non-penumbra balloon device (6mm) was used to stop the bleed under fluoroscopy.The physician reported it is unclear if the guidewire or the flash catheter attributed to the vessel perforation.The patient was reported to be stable and doing well.No additional details regarding the procedure was provided.

• 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: 24596291
• Report Number: 3005168196-2026-00077
• Device Sequence Number: 9015046
• Product Code: QEW
• UDI-Device Identifier: 00810169722541
• UDI-Public: 00810169722541
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K252612
• 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): 03/13/2026

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: F00020224
• 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: 02/15/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2025
• 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: 60 YR
• Patient Sex: Female