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

Catalog Number VEL160STR

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure using a velocity delivery microcatheter (velocity) and a penumbra system ace 68 reperfusion catheter (ace68).During the procedure, while the physician was using the velocity and ace68, the velocity broke in two pieces within the ace68.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a thrombectomy procedure using a velocity delivery microcatheter (velocity), a penumbra system ace 68 reperfusion catheter (ace68), and a stent retriever.During the procedure, the physician completed one pass using the velocity, ace68, and stent retriever.The physician then experienced resistance while advancing the velocity through the ace68 and subsequently, fractured the velocity between the proximal end and mid-shaft.Therefore, the velocity was removed.The procedure was completed using the same ace68 and a new velocity.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were are updated based on additional information provided by a penumbra sales representative: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned velocity confirmed that the velocity was fractured.If the velocity is advanced against resistance during use, damage such as a kink and subsequent fracture may occur.Based on the reported event, the root cause of the resistance could not be determined.Penumbra products are visually 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
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16040550
• MDR Text Key: 307810811
• Report Number: 3005168196-2022-00593
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K100826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VEL160STR
• Device Lot Number: F00000077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1