MAUDE Adverse Event Report: VOLCANO ATHEROMED, INC. PHOENIX ATHERECTOMY SYSTEM, 2.4MM X 130CM, 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number P24130K

Device Problems Defective Device (2588); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2019

Event Type  malfunction  

Event Description

Prepping phoenix device before inserted into patient's leg.Turned device on and device was making a funny noise and was not working correctly.Device was then replaced by another phoenix device.Manufacturer response for phoenix atherectomy, volcano (per site reporter).Return to them to run test.

• Brand Name: PHOENIX ATHERECTOMY SYSTEM, 2.4MM X 130CM, 7F
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): VOLCANO ATHEROMED, INC.; 1530 o'brien drive; suite a; menlo park CA 94025
• MDR Report Key: 8403142
• MDR Text Key: 138214001
• Report Number: 8403142
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P24130K
• Device Lot Number: 01311809
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA