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	09/03/2026
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 a stent retriever to the target location.While removing the velocity, the proximal end fractured.It was reported that the fracture to the velocity occurred outside of the patient.The physician removed the fractured velocity from the patient by hand.A new velocity was used with the stent retriever through the red72 silver.The physician then observed a fracture to the distal end of the velocity under fluoroscopy.The velocity was subsequently removed from the patient in its entirety.The procedure was completed using the stent retriever and red72 silver.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 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: 50932822
• Report Number: 3005168196-2026-00332
• Device Sequence Number: 9509078
• Product Code: DQY
• UDI-Device Identifier: 00814548012629
• UDI-Public: 00814548012629
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/29/2026

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: F00021928
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2026
• 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 Sex: Unknown