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	02/13/2025
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 penumbra system red72 reperfusion catheter (red72), neuron max 6f 088 long sheath (neuron max), velocity delivery microcatheter (velocity) and a guidewire.During the procedure, the physician attempted one pass without success.Next, the physician advanced the red72 over the velocity and guidewire to the target location.The physician then removed the velocity and guidewire together.After removal, the velocity was noticed to be fractured in two locations.The procedure was completed using a non-penumbra microcatheter and the same red72.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned velocity delivery microcatheter (velocity) confirmed fractures on two locations on the proximal end of the microcatheter.This type of fracture typically occurs if the velocity is retracted against resistance.However, based on the reported event, the root cause of this damage could not be determined.Further evaluation revealed an additional fracture on the catheter shaft.The additional fracture was incidental to the complaint and may have occurred during packaging of the device 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.

• 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21579638
• Report Number: 3005168196-2025-00073
• Device Sequence Number: 8832582
• 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): 03/11/2025

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: VEL160STR
• Device Lot Number: F00012139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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 Age: 55 YR
• Patient Sex: Male