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

Catalog Number	VEL160STR
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned velocity delivery microcatheter (velocity) confirmed a fracture on the mid-shaft.If the device is advanced against resistance, damage such as a kink and subsequent fracture may occur.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation revealed an additional fracture, kinks, and ovalization near the distal end.This damage was incidental to the reported complaint.The fracture and kinks may have occurred due to advancement against resistance, and the ovalization may have occurred during packaging 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using a velocity delivery microcatheter (velocity), two non-penumbra catheters, and a guidewire.During the procedure, the physician advanced a parent catheter to the ica.Next, a non-penumbra catheter, the velocity, and the guidewire were advanced into the parent catheter.It was noted that the hospital technician experienced resistance advancing the guidewire into the velocity.The velocity and the guidewire were removed together.After removal, the velocity was noticed to be fractured at the mid-shaft.The entire fractured velocity was removed from the patient.The velocity was not used for the remainder of the procedure.The procedure was completed with the non-penumbra catheters.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: 23969361
• Report Number: 3005168196-2026-00002
• Device Sequence Number: 21503756
• Product Code: DQY
• UDI-Device Identifier: 00814548012629
• UDI-Public: 00814548012629
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/05/2026

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: F00016839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• 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: 80 YR
• Patient Sex: Unknown