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

Catalog Number	LITNGFHT100H1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the patient underwent a thrombectomy procedure in bilateral pulmonary arteries to treat pulmonary embolism (pe) using an indigo system flash aspiration catheter (flash catheter), catheter (6fr pigtail), guidewire (long j wire), and sheaths (7fr and 16fr) via the right groin.During the procedure, the pigtail catheter was advanced and bilateral pulmonary angiograms were taken.Next, the 7fr sheath was upsized to the 16fr sheath.Multiple passes were completed with the flash catheter in the target locations.Post aspiration angiograms showed significant reduction in clot bilaterally.The procedure was completed.The sheath was removed and hemostasis was achieved with a figure 8 suture.It was reported that on (b)(6) 2024, purulent foul-smelling drainage from the right groin at the previous venous sheath site was noted with bleeding, bacteremia was diagnosed and vancomycin was prescribed.On (b)(6) 2024, the patient presented to the emergency department (ed) due to the right groin wound with purulent drainage, no blood, no erythema, and non-tender.The patient was treated with antibiotics and discharged home.Hematoma was reported to be an adverse event with a probable relationship to the indigo aspiration system and to the index procedure.On (b)(6) 2024, the event was considered to be resolved.
Additional Manufacturer Narrative
The product was not returned for evaluation.Therefore, a physical device investigation was unable to be performed.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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: hematoma was previously reported to be an adverse event with a probable relationship to the indigo aspiration system and to the index procedure.However, on 22-jul-2025, an update was received that the previously reported hematoma was determined to be an access site abscess with an unrelated relationship to the indigo aspiration system.Therefore, this event is not considered reportable against the indigo aspiration system.
Event or Problem Description
On (b)(6) 2024, the patient underwent a thrombectomy procedure in bilateral pulmonary arteries to treat pulmonary embolism (pe) using an indigo system flash aspiration catheter (flash catheter), catheter (6fr pigtail), guidewire (long j wire), and sheaths (7fr and 16fr) via the right groin.During the procedure, the pigtail catheter was advanced and bilateral pulmonary angiograms were taken.Next, the 7fr sheath was upsized to the 16fr sheath.Multiple passes were completed with the flash catheter in the target locations.Post aspiration angiograms showed significant reduction in clot bilaterally.The procedure was completed.The sheath was removed and hemostasis was achieved with a figure 8 suture.It was reported that on (b)(6) 2024, purulent foul-smelling drainage from the right groin at the previous venous sheath site was noted with bleeding, bacteremia was diagnosed and vancomycin was prescribed.On (b)(6) 2024, the patient presented to the emergency department (ed) due to the right groin wound with purulent drainage, no blood, no erythema, and non-tender.The patient was treated with antibiotics and discharged home.Hematoma was reported to be an adverse event with a probable relationship to the indigo aspiration system and to the index procedure.On (b)(6) 2024, the event was considered to be resolved.On (b)(6) 2025, an update was provided by the clinical team that the previously reported hematoma was determined to be an access site abscess with an unrelated relationship to the indigo aspiration system.

• 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: 21914013
• Report Number: 3005168196-2025-00137
• Device Sequence Number: 7266382
• Product Code: QEW
• UDI-Device Identifier: 00815948029880
• UDI-Public: 00815948029880
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K241399
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: LITNGFHT100H1
• Device Lot Number: F00013073
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2024
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 106 KG