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	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a velocity delivery microcatheter (velocity), a penumbra system red 72 silver reperfusion catheter (red72 silver), and a stent retriever.The physician used the velocity to deliver the stent retriever to the target vessel and made one pass.While removing the velocity from the patient, the physician experienced resistance.The physician removed the red72 silver, velocity, and stent retriever together.After removal, the velocity was noted to be fractured.It was noted that while removing the velocity from the red72 silver on the back table, the red72 silver fractured.The procedure was completed with a new velocity and new red72 silver.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned velocity delivery microcatheter (velocity) confirmed that the catheter was fractured.It was reported that the velocity fractured upon removal.If the velocity is retracted against resistance, damage such as this may occur.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed that the distal fractured segment of the velocity was stuck inside the red72 silver.This damage likely occurred on the back table during removal of the velocity from the red72 silver.Penumbra devices 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: 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 ; +1(510)748-3200
• MDR Report Key: 50776008
• Report Number: 3005168196-2026-00308
• Device Sequence Number: 16063727
• Product Code: DQY
• UDI-Device Identifier: 00814548012629
• UDI-Public: 00814548012629
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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
• Device Lot Number: F00021064
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2026
• 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: 67 YR
• Patient Sex: Male