MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 7; QEW

Catalog Number	LITNGBT7TQ130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a thrombectomy procedure in the right lower extremity (rle) using an indigo system aspiration catheter 7 (cat7), an indigo system lightning bolt aspiration tubing (lightning bolt), an indigo system separator 7 (sep7), a guidewire (0.035), and a sheath (45cm) via the left groin.It was reported that the procedure was completed, but flow was not able to be restored through the limb.Hemostasis was achieved with a collagen plug.Post-procedure, the patient had continued pain with a cool and mottled right foot with decreased sensation, and pulses were only present at the bypass graft site.The patient required a right above the knee amputation (aka) and in-patient hospitalization due to the limb ischemia.The event was considered resolved on 13-oct-2025.Right lower extremity ischemia was reported to be a serious adverse event with a definite relationship to the indigo aspiration system and a definite relationship to the index procedure.On 24-oct-2025, additional information was received from clinical that right lower extremity ischemia was determined to be a serious adverse event with an unrelated relationship to the indigo aspiration system and an unrelated relationship to the index procedure.On 15-feb-2026, additional information was received from clinical that right lower extremity ischemia was determined by the independent medical reviewer (imr) to be a serious adverse event with a possible relationship to the indigo aspiration system (cat7) and a possible 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.
Event or Problem Description
The patient underwent a thrombectomy procedure in the right lower extremity (rle) using an indigo system aspiration catheter 7 (cat7), an indigo system lightning bolt aspiration tubing (lightning bolt), an indigo system separator 7 (sep7), a guidewire (0.035), and a sheath (45cm) via the left groin.It was reported that the procedure was completed, but flow was not able to be restored through the limb.Hemostasis was achieved with a collagen plug.Post-procedure, the patient had continued pain with a cool and mottled right foot with decreased sensation, and pulses were only present at the bypass graft site.The patient required a right above the knee amputation (aka) and in-patient hospitalization due to the limb ischemia.The event was considered resolved on (b)(6) 2025.Right lower extremity ischemia was reported to be a serious adverse event with a definite relationship to the indigo aspiration system and a definite relationship to the index procedure.On (b)(6) 2025, additional information was received from clinical that right lower extremity ischemia was determined to be a serious adverse event with an unrelated relationship to the indigo aspiration system and an unrelated relationship to the index procedure.On (b)(6) 2026, additional information was received from clinical that right lower extremity ischemia was determined by the independent medical reviewer (imr) to be a serious adverse event with a possible relationship to the indigo aspiration system (cat7) and a possible relationship to the index procedure.On (b)(6) 2026, additional information was received from clinical that right lower extremity ischemia was determined by the independent medical reviewer (imr) to be a serious adverse event with an unrelated relationship to the indigo aspiration system (cat7) and a possible relationship to the index procedure.The imr noted that the patient had profound acute limb ischemia (ali) on presentation and had multiple attempts at mechanical thrombectomy and thrombolysis, without acute benefit or resolution.It was reported that this was not a device/drug issue, but rather a clinical event that was quite difficult to treat and unfortunately an undesired outcome.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the penumbra clinical team: 1.Section b.Box 5.Describe event or problem.Note: right lower extremity ischemia was previously reported to be a serious adverse event with a possible relationship to the indigo aspiration system and to the index procedure.However, on (b)(6) 2026, an update was received that the previously reported right lower extremity ischemia was determined to have an unrelated relationship to the indigo aspiration system.Therefore, this event is not considered reportable against the indigo aspiration system.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 7
• 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: 24594339
• Report Number: 3005168196-2026-00072
• Device Sequence Number: 10474613
• Product Code: QEW
• UDI-Device Identifier: 00815948025462
• UDI-Public: 00815948025462
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K223186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: LITNGBT7TQ130
• Device Lot Number: H00007542
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• 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; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male