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

Catalog Number	LITNGFHT100H1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Low Blood Pressure/ Hypotension (1914)
Date of Event	10/18/2024
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 pulmonary artery using an indigo system lightning flash aspiration tubing (flash tubing), an indigo system flash aspiration catheter (flash catheter), a non-penumbra flush catheter (16fr), and a non-penumbra flowtriever system.The procedure was completed.There was no report of an adverse effect to the patient.On (b)(6) 2025, one day post-procedure, it was reported that the patient developed hypotension in the setting of low hemoglobin (hgb).At 9:58am the blood pressure was 113/70.At 11:45am the blood pressure was 83/54.Pre-procedure, the hgb was 12.1, one-day post index procedure, the hgb was 8.0.Two-day post index procedure, the hgb was 8.0.A blood transfusion was given.Low blood pressure was determined by the independent medical reviewer (imr) to be a serious adverse event with a possible relationship to the indigo aspiration system and a probable relationship to the index procedure.The event was considered to be resolved with clinical sequelae on (b)(6) 2024.Low hemoglobin was determined by the imr to be a serious adverse event with a possible relationship to the indigo aspiration system and a probable relationship to the index procedure.The event was considered to be resolved on (b)(6) 2024.The patient had a 90-day follow-up visit on (b)(6) 2025.

• Brand Name: INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING
• 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: 21610833
• Report Number: 3005168196-2025-00081
• Device Sequence Number: 18058050
• Product Code: QEW
• UDI-Device Identifier: 00815948029880
• UDI-Public: 00815948029880
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K240030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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: F00012655
• 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: 02/18/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 76 KG