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

Catalog Number	LITNGFHT115H1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemoptysis (1887)
Date of Event	03/22/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Hemoptysis and death are included as possible complications in the instructions for use (ifu) for the indigo aspiration system.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 to treat an acute pulmonary embolism in the left pulmonary artery (lpa) and right segmental branches using an indigo system lightning flash aspiration tubing (flash tubing) and an indigo system flash aspiration catheter (flash catheter).It was noted that the patient had a right ventricular (rv) strain.During the procedure, the flash catheter was advanced into the lpa without issues and aspiration was initiated.After approximately three minutes of aspiration, the patient began to cough up blood and the procedure was aborted.The physician then advanced a balloon catheter to stabilize the patient and performed an angiogram.However, the physician could not find an area of perforation.It was reported that the patient developed airway obstruction, and cardiopulmonary arrest.Resuscitation efforts that included advanced cardiovascular life support (acls) intervention, cricothyrotomy, and mechanical ventilation were performed.The patient was also administered protamine sulfate, two units of fresh red blood cells (prbcs), and two units of fresh frozen plasma (ffp).The patient was able to regain a strong pulse for a short time.After approximately 37 minutes, the patient expired.The death was reported to be a serious adverse event with a possible relationship to the indigo aspiration system, and a definite relationship to the procedure.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up mfr report: 3004168196-2025-00125.Section h.Box 6.Health effect impact code 3.Please note the following updated information: the product was not returned for evaluation.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.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by penumbra clinical team on 27-may-2025: 1.Section b.Box 5.Describe event or problem.Note: the death was previously reported to be a serious adverse event with a possible relationship to the indigo aspiration system and a definite relationship to the procedure.On 27-may-2025, an update was received indicating that the cause of death was hemoptysis.Hemoptysis was unrelated to the indigo aspiration system.Therefore, this event is not considered reportable against the indigo aspiration system.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an acute pulmonary embolism in the left pulmonary artery (lpa) and right segmental branches using an indigo system lightning flash aspiration tubing (flash tubing) and an indigo system flash aspiration catheter (flash catheter).It was noted that the patient had a right ventricular (rv) strain.During the procedure, the flash catheter was advanced into the lpa without issues and aspiration was initiated.After approximately three minutes of aspiration, the patient began to cough up blood and the procedure was aborted.The physician then advanced a balloon catheter to stabilize the patient and performed an angiogram.However, the physician could not find an area of perforation.It was reported that the patient developed airway obstruction, and cardiopulmonary arrest.Resuscitation efforts that included advanced cardiovascular life support (acls) intervention, cricothyrotomy, and mechanical ventilation were performed.The patient was also administered protamine sulfate, two units of fresh red blood cells (prbcs), and two units of fresh frozen plasma (ffp).The patient was able to regain a strong pulse for a short time.After approximately 37 minutes, the patient expired.The death was reported to be a serious adverse event with a possible relationship to the indigo aspiration system, and a definite relationship to the procedure.On 27-may-2025 an update was received indicating that the adverse event was updated to hemoptysis and that the event was unrelated to the indigo aspiration system.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an acute pulmonary embolism in the left pulmonary artery (lpa) and right segmental branches using an indigo system lightning flash aspiration tubing (flash tubing) and an indigo system flash aspiration catheter (flash catheter).It was noted that the patient had a right ventricular (rv) strain.During the procedure, the flash catheter was advanced into the lpa without issues and aspiration was initiated.After approximately three minutes of aspiration, the patient began to cough up blood and the procedure was aborted.The physician then advanced a balloon catheter to stabilize the patient and performed an angiogram.However, the physician could not find an area of perforation.It was reported that the patient developed airway obstruction, and cardiopulmonary arrest.Resuscitation efforts that included advanced cardiovascular life support (acls) intervention, cricothyrotomy, and mechanical ventilation were performed.The patient was also administered protamine sulfate, two units of fresh red blood cells (prbcs), and two units of fresh frozen plasma (ffp).The patient was able to regain a strong pulse for a short time.After approximately 37 minutes, the patient expired.The death was reported to be a serious adverse event with a possible relationship to the indigo aspiration system, and a definite relationship to the procedure.On 27-may-2025 an update was received indicating that the adverse event was updated to hemoptysis and that the event was unrelated to the indigo aspiration system.On 19-june-2025, additional information indicated that the clinical events committee (cec) adjudicated the event to have a probable relationship to the indigo aspiration system and the index procedure.On 9-july-2025, the cec updated the adjudication from probable to possible relationship to the indigo aspiration system and the index procedure.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by penumbra clinical team on 19-jun-25: 1.Section b.Box 2.Outcomes attributed to adverse event.2.Section b.Box 5.Describe event or problem.3.Section h.Box 6.Health effect impact code 3.Note: the patient's death was previously reported to be a serious adverse event with a possible relationship to the indigo aspiration system and a definite relationship to the procedure.On 27-may-25, the adverse event was updated from death to hemoptysis.The hemoptysis was reported to be unrelated to the indigo aspiration system.However, on 19-june-2025, the clinical events committee (cec) adjudicated the adverse event of hemoptysis to have a probable relationship to the indigo aspiration system and the index procedure.On 09-july-2025, the cec updated the adjudication from probable to possible relationship to the indigo aspiration system and the index procedure.Per the autopsy report, the patient's cause of death was due to ongoing hemorrhage as a result of reperfusion injury after the pulmonary embolism was evacuated from the pulmonary vasculature.There was no evidence of mechanical disruption to the vessels or the airways.

• 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: 21862567
• Report Number: 3005168196-2025-00125
• Device Sequence Number: 20004761
• Product Code: QEW
• UDI-Device Identifier: 00815948029873
• UDI-Public: 00815948029873
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K240030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/18/2025

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: LITNGFHT115H1
• Device Lot Number: F00013462
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: Not provided; 05/27/2025; 06/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 04/21/2025; 05/30/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2024
• 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; Death
• Patient Age: 70 YR
• Patient Sex: Male