MAUDE Adverse Event Report: PENUMBRA, INC. VELOCITY DELIVERY MICROCATHETER; DQY

Catalog Number	VEL160STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure for a stroke using a velocity delivery microcatheter (velocity).It was reported that the velocity had fractured approximately at the proximal end to the midshaft.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the penumbra sales representative on 27-mar-2026: 1.Section b.Box 5.Describe event or problem.Note: based on the new information, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious injury or death.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) for a stroke using a velocity delivery microcatheter (velocity), a non-penumbra aspiration catheter, a non-penumbra guide catheter, and a guidewire.The physician advanced the aspiration catheter containing the velocity over the guidewire and into the target location.The physician then removed the velocity together with the guidewire.While removing the velocity off from the guidewire on the back table, the velocity had fractured at the proximal midshaft.The procedure was completed with one pass using the aspiration catheter.There was no report of an adverse effect to the patient.

• Brand Name: VELOCITY DELIVERY MICROCATHETER
• Common Device Name: DQY
• 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: 24705634
• Report Number: 3005168196-2026-00098
• Device Sequence Number: 10046859
• Product Code: DQY
• UDI-Device Identifier: 00814548012629
• UDI-Public: 00814548012629
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K100826
• 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): 04/03/2026

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: VEL160STR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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