MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 7; QEW

Catalog Number	LITNGBT7TQ130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
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 using an indigo system aspiration catheter 7 (cat7), a sheath, and a guidewire.During the procedure, the physician advanced the cat7 over the guidewire to the target location and then removed the guidewire.The physician began to torque the cat7.While torquing, the cat7 fractured at the hub.It was reported that a wire was backloaded through the cat7 and the cat7 was removed from the patient successfully.The procedure was completed using a new cat7.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Note: although the event summary alleged a deterioration in the characteristics or performance of the device, this event did not and, if it were to recur, it would not cause or contribute to a serious injury or death.Therefore, this is not considered a reportable event.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 7 (cat7), a sheath, and a guidewire.During the procedure, the physician advanced the cat7 over the guidewire to the target location and then removed the guidewire.The physician began to torque the cat7.While torquing, the cat7 fractured at the hub.It was reported that a wire was backloaded through the cat7 and the cat7 was removed from the patient successfully.The procedure was completed using a new cat7.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 7
• 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21910356
• Report Number: 3005168196-2025-00131
• Device Sequence Number: 15652255
• Product Code: QEW
• UDI-Device Identifier: 00815948025462
• UDI-Public: 00815948025462
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K223186
• 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): 07/25/2025

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 Catalogue Number: LITNGBT7TQ130
• Device Lot Number: H00006049
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• 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 Sex: Unknown