MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6X; QEW

Catalog Number	LITNGBT6XTX
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the popliteal artery using an indigo system aspiration catheter 6x (cat6x), a trax delivery device (trax), and a non-penumbra sheath (6f).During the procedure, while advancing the cat6x with the trax, the physician experienced resistance and kinked the cat6x at the distal end.While removing the cat6x with the trax, the cat6x became stretched.The physician continued to retract the cat6x and the cat6x fractured at the distal end.The proximal end of the cat6x and the trax were removed.A vascular surgeon performed a surgical cutdown in the popliteal artery to remove the remaining segment of the cat6x.No portion of the cat6x remained in the patient¿s body.The procedure was completed with open thrombectomy.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned indigo system aspiration catheter 6x (cat6x) confirmed that the device was fractured.Evaluation revealed stretching at the fractured location.If the cat6x is retracted against resistance during use, damage such as stretching and fracture may occur.The root cause of the resistance during the procedure could not be determined.Further evaluation revealed an additional fracture, bends on the cat6x and a bend on the trax delivery device.This damage is incidental to the reported complaint and may have occurred during removal or packaging for return to penumbra.Penumbra devices 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.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6X
• 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: 24512097
• Report Number: 3005168196-2026-00061
• Device Sequence Number: 13251760
• Product Code: QEW
• UDI-Device Identifier: 00810169721186
• UDI-Public: 00810169721186
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K242319
• 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): 03/04/2026

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: LITNGBT6XTX
• Device Lot Number: F00014159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Female