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 Codes	Thrombosis/Thrombus (4440); Retroperitoneal Hemorrhage (4483)
Date of Event	05/15/2025
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 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 popliteal, femoral and iliac veins using an indigo system flash aspiration catheter (flash catheter), balloon catheters, a stent, guidewires, and a sheath.During the procedure, the flash catheter was advanced into the target location and several passes were made.An angiogram was taken and an extravasation was noted at the iliocaval junction/retroperitoneal area.A balloon catheter was inflated in the extravasation area for five minutes and the issue resolved.The physician then continued the procedure.The procedure was completed with the same flash catheter.It was reported that the patient remained stable during the procedure and post-procedure.Retroperitoneal bleed 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left popliteal, femoral and iliac veins using an indigo system flash aspiration catheter (flash catheter), balloon catheters, a stent, guidewires, and a sheath.During the procedure, the flash catheter was advanced into the target location and several passes were made.An angiogram was taken and an extravasation was noted at the iliocaval junction/retroperitoneal area.A balloon catheter was inflated in the extravasation area for five minutes and the issue resolved.The physician then continued the procedure.The procedure was completed with the same flash catheter.It was reported that the patient remained stable during the procedure and post-procedure.Retroperitoneal bleed 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 11-jun-2025, additional information was received that on (b)(6) 2025, the patient returned with swelling and pain and was found to have extensive acute clot in the majority of the left leg.Re-thrombosis of target vessel was reported to be a serious adverse event with a probable relationship to the indigo aspiration system and a probable relationship to the index procedure.
Additional Manufacturer Narrative
Please note that the following sections were updated based on additional information provided by the penumbra clinical team on 11 jun 2025: 1.Section b.Box 5.Describe event or problem.2.Section h.Box 6.Health effect clinical code 1 & health effect clinical code 2.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left popliteal, femoral and iliac veins using an indigo system flash aspiration catheter (flash catheter), balloon catheters, a stent, guidewires, and a sheath.During the procedure, the flash catheter was advanced into the target location and several passes were made.An angiogram was taken and an extravasation was noted at the iliocaval junction/retroperitoneal area.A balloon catheter was inflated in the extravasation area for five minutes and the issue resolved.The physician then continued the procedure.The procedure was completed with the same flash catheter.It was reported that the patient remained stable during the procedure and post-procedure.Retroperitoneal bleed 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 that on (b)(6) 2025, the patient returned with swelling and pain and was found to have extensive acute clot in the majority of the left leg.Re-thrombosis of target vessel was reported to be a serious adverse event with a probable relationship to the indigo aspiration system and a probable relationship to the index procedure.On (b)(6) 2026, additional information was received indicating that the cec adjudicated retroperitoneal bleed as an adverse event with a possible relationship to the indigo aspiration system and a probable relationship to the index procedure.The cec also adjudicated re-thrombosis of target vessel as an adverse event with an unrelated relationship to the indigo aspiration system and a possible relationship to the index procedure.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by the penumbra clinical team on (b)(6) 2026.1.Section b.Box 5.Describe event or problem 2.Section h.Box 6.Health effect clinical code 1 and health effect clinical code 2.

• 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22179313
• Report Number: 3005168196-2025-00196
• Device Sequence Number: 13196509
• Product Code: QEW
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K240030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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: F00014196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/11/2025; 04/27/2026
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/09/2025; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 165 LB