MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 12; QEW

Catalog Number	LITNG12XTORQ100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	03/11/2025
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 product lot number was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
On (b)(6) 2025, the patient underwent a thrombectomy procedure in the pulmonary arteries and right ventricle (rv) using an indigo system aspiration catheter 12 (cat12), an indigo system separator 12 (sep12), and a penumbra engine (engine).During the procedure, the physician removed thrombus from the target vessels.However, it was reported residual clot remained in the rv.There were no reported procedural complications.Following the procedure, the patient received a 10-hour infusion of intra-arterial tpa alteplase.On (b)(6) 2025, one day post procedure, the patient¿s vital signs were stable, with a heart rate of 80 beats per minute, a respiratory rate of 18 breaths per minute, and an oxygen saturation of 99%.On (b)(6) 2025, two days post procedure, the patient reported recurrent dyspnea.At that time, the heart rate had increased to 120 beats per minute, the respiratory rate to 36 breaths per minute, and the oxygen saturation had decreased to 80%.It was reported that there was thrombus migration from the rv to the pulmonary artery.The patient was given intravenous (iv) infusion (norepinephrine & dobutamine) and underwent a thrombectomy procedure to treat the migrated thrombus.After the thrombectomy procedure, the physician performed an echocardiogram and noticed that the rv clot was no longer present.The event was considered resolved and the patient was discharged on (b)(6) 2025.The mobilization of thrombus was reported as a serious adverse event, with a possible relationship to the indigo aspiration system (cat12), the index procedure and thrombolytics.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 12
• 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: 24614503
• Report Number: 3005168196-2026-00082
• Device Sequence Number: 13220176
• Product Code: QEW
• UDI-Device Identifier: 00815948022911
• UDI-Public: 00815948022911
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K202821
• 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): 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: LITNG12XTORQ100
• 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: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 53 YR
• Patient Sex: Male