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	Perforation of Vessels (2135)
Date of Event	05/26/2026
Type of Reportable Event	Death
Event or Problem Description
The patient underwent a bilateral pulmonary artery mechanical thrombectomy using an indigo system flash aspiration catheter (flash catheter), an angled pigtail catheter, a non-penumbra 17f sheath, and guidewires.Toward the end of the procedure, following thrombus removal from the large branches, a small amount of thrombus remained in the subsegmental branches.The patient developed dyspnea, tachycardia, and pallor.Angiographic imaging acquired during the procedure demonstrated contrast staining of the cardiac border with contrast extending into the left pleural space consistent with pulmonary vascular injury, and a pleural effusion that developed as the procedure progressed.The effusion was corroborated by chest x-ray.Heparin was reversed with 50 mg of protamine, and balloon tamponade was performed in the left lower segmental pulmonary artery using a balloon device.Following tamponade, repeat angiography demonstrated no further extravasation.The patient's respiratory status continued to deteriorate, and the procedure was terminated for further stabilization.The patient was transferred to the post-anesthesia care unit, where furosemide was administered and bipap/respiratory therapy was provided.The patient continued to deteriorate.Intravenous milrinone was initiated the patient was transferred to the intensive care unit.A rapid response was called, followed by intubation and code events.Despite extensive medical intervention and supportive measures, the patient's clinical condition continued to deteriorate and the patient expired.Major bleeding, pulmonary vascular injury, and death were classified under the event of cardiogenic shock.The independent medical reviewer (imr) adjudicated the cardiogenic shock as a serious adverse event (sae) with a possible relationship to the indigo aspiration system and a definite relationship to the index procedure.The imr noted that the source of the vascular injury could not be definitively attributed between a guidewire and the device.The device was not returned and was not available for evaluation.
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 menezes ; one penumbra place; alameda, CA 94502 ; +1(510)748-3200
• MDR Report Key: 50573082
• Report Number: 3005168196-2026-00292
• Device Sequence Number: 9873138
• Product Code: QEW
• UDI-Device Identifier: 00810169722534
• UDI-Public: 00810169722534
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K252612
• 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): 09/02/2026

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: LITNGFHT100H1
• Device Lot Number: F00021000
• 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: 08/04/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2026
• 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: 70 YR
• Patient Sex: Female