MAUDE Adverse Event Report: VOLCANO CORPORATION EAGLE EYE PLATINUM; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Catalog Number 85900P

Device Problems Difficult to Remove (1528); Communication or Transmission Problem (2896); Positioning Problem (3009)

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

Event Date 07/17/2017

Event Type  malfunction  

Event Description

Upon completion of angiography, dr wanted to use intravascular ultrasound (ivus) on the right coronary artery (rca).Supplies were opened and ivus catheter was prepped.Dr stated that the mandril was difficult to remove from the catheter.We proceeded to load it on the wire and ring down.Once we started recording we got a defective signal.A new one was used and worked just fine.

• Brand Name: EAGLE EYE PLATINUM
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore rd; rancho cordova CA 95670
• MDR Report Key: 6766918
• MDR Text Key: 81814156
• Report Number: 6766918
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 85900P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.; NOT SURE,
• Patient Age: 84 YR