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	Foreign Body In Patient (2687)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned indigo system catrx aspiration catheter (catrx) confirmed it was fractured.Evaluation revealed signs of torquing at the fracture location.If the catrx is torqued unrestrained against resistance, damage such as fracture may occur.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation revealed ovalizations and bends along the catheter.This damage was incidental to the complaint and may have occurred during packaging for return.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 anterior tibial artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, and a guidewire.The physician completed one pass using the catrx.After the completion of the procedure, the physician observed under fluoroscopy that the catrx fractured at the distal end in the common femoral artery (cfa).The patient was transferred to the operating room and a cutdown surgery was performed to remove the fractured catrx.No portion of the catrx was left in the patient's body.It was reported that the patient was discharged the next day and was doing fine.

• 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: 24602356
• Report Number: 3005168196-2026-00080
• Device Sequence Number: 20921625
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/15/2026

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: CATRXKIT
• Device Lot Number: F00018694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female