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

Catalog Number	CATRXKIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned indigo system catrx aspiration catheter (catrx) confirmed that the catheter was fractured and was returned inside the non-penumbra device.Further evaluation revealed that the catheter was kinked at the fractured location.This indicates that the device likely kinked prior to fracturing.If the catrx is manipulated against resistance or at an angle during use, damage such as a kink and subsequent fracture may occur.Based on the reported complaint, the root cause could not be determined.Further evaluation revealed bends along the length of the catrx and non-penumbra device.This damage was incidental to the complaint and the root cause 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 left anterior descending artery (lad) using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, a guide catheter (6f), and a guidewire.Two passes were completed using the catrx.The catrx was then removed for flushing.Upon removal, the catrx fractured.The guide catheter containing the fractured catrx segment was removed.It was reported that no portion of the catrx was left in the patient.The procedure ended at this point and the patient was administered tissue plasminogen activator (tpa).There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CATRX ASPIRATION CATHETER
• Common Device Name: QEX, 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: 24758657
• Report Number: 3005168196-2026-00105
• Device Sequence Number: 15646454
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K220683
• 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): 04/01/2026

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: CATRXKIT
• Device Lot Number: F00018143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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: 72 YR
• Patient Sex: Male