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

Catalog Number	CATRXKIT
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned, and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in a coronary artery using an indigo system catrx aspiration catheter (catrx) and a guidewire.During advancement of the catrx over the guidewire and into the patient, the physician encountered resistance, and the catrx became stuck on the guidewire.While retracting the catrx against resistance in order to clean the guidewire, the catrx fractured at the proximal end of the guidewire lumen.It was noted that all portions of the catrx were removed.The procedure was completed using a new catrx.No additional information was provided.There were no reported adverse effects to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow-up #01: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned indigo system catrx aspiration catheter (catrx) confirmed that the catheter was fractured.If the catrx is advanced against resistance, damage such as a kink may occur.Upon further manipulation of a kinked device, the kink may worsen to a fracture.Further evaluation revealed that the catrx was stretched on its distal shaft and the guidewire lumen was kinked at the distal tip.This damage was incidental to the reported complaint.The stretching likely occurred during retraction against resistance and the root cause of the kink at the distal tip of the guidewire lumen 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 a coronary artery using an indigo system catrx aspiration catheter (catrx) and a guidewire.During advancement of the catrx over the guidewire and into the patient, the physician encountered resistance, and the catrx became stuck.While retracting the catrx against resistance, the catrx fractured.It was noted that all fragments of the catrx were removed.The procedure was completed using a new catrx.No additional information was provided.There were no reported adverse effects 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: 24849082
• Report Number: 3005168196-2026-00122
• Device Sequence Number: 8946683
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: F00018302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2025
• 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: 71 YR
• Patient Sex: Male