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

Catalog Number	LITNGFHT100BER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	01/12/2025
Type of Reportable Event	Death
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left iliac and femoral vein for a deep vein thrombosis (dvt) using an indigo system lightning flash aspiration tubing (flash tubing), an indigo system flash aspiration catheter (flash catheter), a balloon (10x40), guidewires, a microsheath, and sheaths (6fr and 16fr) in a prone position via the left lower extremity.During the procedure, an initial venogram was taken which showed extensive clot in the femoral, common femoral, and iliac venous system.The 6fr sheath was upsized to a 16fr sheath.Several passes were made in the target location using the flash catheter.A venogram showed some residual narrowing of the common femoral and femoral vein so an angioplasty was performed with a balloon catheter.A post-intervention venogram showed no residual stenosis.The vein was widely patent.The flash catheter and sheath were then removed from the patient.The procedure was completed and the patient was placed in a supine position on the stretcher.It was reported that the patient was getting ready to be extubated and began to experience oxygen desaturation and tachycardia, which became progressively worse.The patient then became hypotensive and bradycardic.A code was called, multiple rounds of medications were given, and 3 rounds of cardiopulmonary resuscitation (cpr) were performed.Two units of packed red blood cells (prbcs) were transfused.The patient was able to regain her blood pressure.The physician suspected that the patient had a pulmonary embolism, so an interventional radiologist was consulted.Once the patient was stable, she was moved back onto the table.The patient underwent a thrombectomy procedure in bilateral pulmonary arteries for pulmonary embolism using non-penumbra catheters, a non-penumbra thrombectomy system, and a sheath (6fr) via the right groin.Post-intervention angiogram demonstrated scattered bilateral segmental and subsegmental emboli.The catheter and sheath were removed, and hemostasis was achieved.The procedure was completed and the patient was transferred to the intensive care unit (icu).It was reported that the patient's condition continued to deteriorate with maximum pressor support, and the patient was shocked twice with no improvement in status.The family decided to withdraw care, and the patient expired on (b)(6) 2025.The cec chair adjudicated shock/hemodynamic instability due to pulmonary embolism to be a serious adverse event with a probable relationship to the index procedure and a possible relationship to the indigo aspiration system.
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.

• 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: 21955399
• Report Number: 3005168196-2025-00152
• Device Sequence Number: 20649343
• Product Code: QEW
• UDI-Device Identifier: 00815948029446
• UDI-Public: 00815948029446
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 05/02/2025

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: LITNGFHT100BER
• Device Lot Number: C00015134
• 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: 04/10/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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: Death
• Patient Age: 69 YR
• Patient Sex: Female