MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 3 ASPIRATION CATHETER; QEW

Catalog Number	CAT3KIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 the anterior tibial artery (ata) using an indigo system cat3 aspiration catheter (cat3), a sheath, and a guidewire (.14).During the procedure, while advancing the cat3 to the target vessel, the physician lost track of the radiopaque tip of the cat3 and then noticed under fluoroscopy that the marker had already reached beyond the occluded segment of the ata, reaching the dorsalis pedis artery.The physician began retracting the cat3 but noticed under fluoroscopy that the radiopaque tip of the cat3 remained in the dorsalis pedis artery.The cat3 was removed and upon inspection, the physician noticed that approximately twenty centimeters of the distal length of the cat3 remained in the patient.The physician performed a surgical cut-down of the dorsalis pedis artery and successfully retrieved the fractured segment of the cat3.The procedure was completed.It was reported that the patient remains hospitalized, under observation.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned indigo system cat3 aspiration catheter (cat3) confirmed that the catheter was fractured.This damage typically occurs if the cat3 is manipulated against resistance.The reported advancement of the cat3 beyond the occlusion into more distal, narrow anatomy likely contributed to the fracture experienced during the procedure.Further evaluation revealed an ovalization on the cat3.This damage is incidental to the complaint and may have occurred during packaging of the device 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.

• Brand Name: INDIGO SYSTEM CAT 3 ASPIRATION CATHETER
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502
• MDR Report Key: 22937494
• Report Number: 3005168196-2025-00283
• Device Sequence Number: 9800891
• Product Code: QEW
• UDI-Device Identifier: 00815948020535
• UDI-Public: 00815948020535
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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 Expiration Date: 06/13/2026
• Device Catalogue Number: CAT3KIT
• Device Lot Number: C00013013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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: 57 YR
• Patient Sex: Male