MAUDE Adverse Event Report: VOLCANO VISIONS DIGITAL IVUS CATHETER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 86700

Device Problem Break (1069)

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

Event Date 11/15/2019

Event Type  malfunction  

Event Description

Ivus catheter fell apart prior to insertion into pt.All pieces retrieved.Rep present and aware.Fda safety report id# (b)(4).

• Brand Name: VOLCANO VISIONS DIGITAL IVUS CATHETER
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 9411820
• MDR Text Key: 169238921
• Report Number: MW5091429
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 86700
• Device Catalogue Number: 989609002431
• Device Lot Number: 0301713200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR