MAUDE Adverse Event Report: VOLCANO CORPORATION VOLCANO VISIONS RX DIGITAL IVUS CATHETER; TRANSDUCER, ULTRA SONIC, DIAGNOSTIC

Catalog Number 014R

Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 02/26/2019

Event Type  malfunction  

Event Description

When the catheter was plugged in for use once in the body of the patient, the monitor read ¿ not recognizable¿.The catheter was removed from the body and a new one was placed.

• Brand Name: VOLCANO VISIONS RX DIGITAL IVUS CATHETER
• Type of Device: TRANSDUCER, ULTRA SONIC, DIAGNOSTIC
• Manufacturer (Section D): VOLCANO CORPORATION
• MDR Report Key: 8381833
• MDR Text Key: 137685816
• Report Number: MW5084527
• Device Sequence Number: 1
• Product Code: ITX
• 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: 02/27/2019

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: 07/31/2020
• Device Catalogue Number: 014R
• Device Lot Number: 989609001091
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2019
• 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: 80 DA