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

Catalog Number	LITNGBT6XTX150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up mfr report: 1.Section d.Box 8.Was this device serviced by a third party?.
Additional Manufacturer Narrative
Evaluation of the returned indigo system aspiration catheter 6x (cat6x) confirmed a fracture on the mid-shaft.This type of damage typically occurs if the cat6x is retracted against resistance during use.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed kinks on the proximal end and distal to the fracture.This damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.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 left lower extremity anterior tibial artery using an indigo system aspiration catheter 6x (cat6x), a non-penumbra sheath, and a guidewire.During the procedure, the physician completed one pass using the cat6x.The cat6x was removed from the patient along with the guidewire.After removal, the physician noticed that the cat6x mid-shaft was fractured.The cat6x was not used for the remainder of the procedure.The physician completed the procedure by administering tissue plasminogen activator (tpa), an indigo system aspiration catheter 7 (cat7) and the same sheath.There was no report of an adverse effect on the patient.

• 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: 24173026
• Report Number: 3005168196-2026-00029
• Device Sequence Number: 13306600
• Product Code: QEW
• UDI-Device Identifier: 00810169722466
• UDI-Public: 00810169722466
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 02/12/2026

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: LITNGBT6XTX150
• Device Lot Number: F00018234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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: 29 YR
• Patient Sex: Unknown