MAUDE Adverse Event Report: VOLCANO CORPORATION IVUS CATHETER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Lot Number 0302590296

Device Problem Activation Failure (3270)

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

Event Date 07/29/2022

Event Type  malfunction  

Event Description

Ivus catheter did not work.Ivus interface said "ivus faulted".

• Brand Name: IVUS CATHETER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): VOLCANO CORPORATION
• MDR Report Key: 16323487
• MDR Text Key: 309145649
• Report Number: MW5114763
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0302590296
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male