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

Catalog Number	LITNGFHT115BER
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 a pulmonary embolism in the right and left lungs using an indigo system flash aspiration catheter (flash catheter).It should be noted that the patient was already in critical condition and in a coma prior to before the procedure, with a chronic thrombus present in one lung and hemodynamic instability.During the procedure, the physician successfully aspirated thrombus in one lung using the flash catheter.While repositioning the flash catheter to other lung where thrombus was located, the patient went into cardiac arrest.The medical team attempted to resuscitate the patient but the patient ultimately expired.There was no damage noted on the flash catheter under fluoroscopy.After the patient expired, the flash catheter from the patient.The physician noticed that the distal length of the flash catheter was fractured.A snare device was used to remove the fractured flash catheter from the patient.The physician determined that the damage to the flash catheter may have occurred due to excessive resuscitation efforts.It was also reported that the flash catheter did not cause or contribute to the patient's death.
Additional Manufacturer Narrative
Please note that the following sections have been corrected on this follow-up mfr report: 1.Section b.Box 1.Adverse event and/or product problem, 2.Section b.Box 2.Outcomes attributed to adverse event, date of death, 3.Section h.Box 1.Type of reportable event, 4.Section h.Box 6.Health effect clinical code, 5.Section h.Box 6.Health effect impact codes.

• 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 94502 ; 5107483200
• MDR Report Key: 22742292
• Report Number: 3005168196-2025-00255
• Device Sequence Number: 8506978
• Product Code: QEW
• UDI-Device Identifier: 00815948029453
• UDI-Public: 00815948029453
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: LITNGFHT115BER
• Device Lot Number: F00013123
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• 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: 72 YR
• Patient Sex: Female