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

Catalog Number	LITNG12HTORQ115
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right and left lungs using an indigo system aspiration catheter 12 (cat12) and a non-penumbra catheter.During the procedure, while advancing the cat12 using the catheter, the physician experienced difficulty and while introducing the cat12 through the right ventricle to the pulmonary arteries.At that time, the patient decompensated, presenting with bradycardia, hypotension, followed by a pause in the cardiac rhythm.The physician then administered medication.No additional information regarding the completion of the procedure was provided.On (b)(6) 2025, the event was considered resolved.The decompensation with bradycardia and hypotension was reported to be a serious adverse event with a probable relationship with the indigo system aspiration catheter 12 and the index procedure.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 right and left lungs using an indigo system aspiration catheter 12 (cat12) and a non-penumbra catheter.During the procedure, while advancing the cat12 using the catheter, the physician experienced difficulty and while introducing the cat12 through the right ventricle to the pulmonary arteries.At that time, the patient decompensated, presenting with bradycardia, hypotension, followed by a pause in the cardiac rhythm.The physician then administered medication (atropine and dobutamine).No additional information regarding the completion of the procedure was provided.On (b)(6) 2025, the event was considered resolved.The decompensation with bradycardia and hypotension was reported to be a serious adverse event with a probable relationship with the indigo aspiration system (cat12) and the index procedure.On 16-jan-2026, clarification was received indicating that the sudden onset of bradycardia, followed by a pause in cardiac rhythm, occurred during the introduction of a non-penumbra sheath into the pulmonary artery, and prior to advancement of the cat12.The previously reported episode of decompensation with bradycardia and hypotension was subsequently determined to be unrelated to the cat12.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra clinical team on 16jan2026: 1.Section b.Box 5.Describe event or problem.The initial complaint reported that while the indigo system aspiration catheter 12 (cat12) was being advanced through the right ventricle toward the pulmonary arteries, the patient decompensated, exhibiting bradycardia, hypotension, and a subsequent pause in cardiac rhythm.However, additional information received from the clinical site on 16jan2026 indicated that the sudden onset of bradycardia, followed by a pause in cardiac rhythm, occurred during the introduction of a non-penumbra sheath into the pulmonary artery, and prior to advancement of the cat12.Therefore, this event is not considered reportable against the cat12.

• 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 23660861
• Report Number: 3005168196-2025-00378
• Device Sequence Number: 9082419
• Product Code: QEW
• UDI-Device Identifier: 00815948022928
• UDI-Public: 00815948022928
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2026

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: LITNG12HTORQ115
• Device Lot Number: H00005677
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 04/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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: 78 YR
• Patient Sex: Female