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

Catalog Number	LITNGFHT80H1
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned indigo system flash aspiration catheter (flash catheter) confirmed it was fractured.Evaluation revealed signs of torquing at the fracture site.If the flash catheter is torqued unrestrained against resistance during retraction, damage such as this may occur.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.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 flash aspiration catheter (flash catheter), an indigo system lightning flash aspiration tubing (flash tubing), a non-penumbra sheath, and a guidewire.During the procedure, while retracting the flash catheter after completing the final pass, the physician experienced resistance, and the distal end of the flash catheter fractured in the pulmonary artery.The flash catheter fracture was noticed under fluoroscopy.The proximal portion of the flash catheter was successfully removed.The physician used a non-penumbra sheath (24f) and a non-penumbra snare device to retrieve the fractured segment of the flash catheter from the patient.The procedure was completed at this point.There was no report of an adverse effect to the patient.

• 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 ; 5107483200
• MDR Report Key: 23936035
• Report Number: 3005168196-2025-00418
• Device Sequence Number: 18548385
• Product Code: QEW
• UDI-Device Identifier: 00815948029897
• UDI-Public: 00815948029897
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K241399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: LITNGFHT80H1
• Device Lot Number: F00016131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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
• Patient Age: 58 YR
• Patient Sex: Male