MAUDE Adverse Event Report: VOLCANO CORPORATION VERRATA; TRANSDUCER, PRESSURE, CATHETER TIP

Catalog Number 10185

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/03/2017

Event Type  malfunction  

Event Description

The guide wire seemed to be working great in the first attempt, while doing instantaneous free-wave ratio (ifr) on the right coronary artery (rca).When we moved out and work in a different vessel it wouldn't work, tried to disconnect and reconnect from system but still didn't work.A new wire was used and worked fine.

• Brand Name: VERRATA
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore rd; rancho cordova CA 95670
• MDR Report Key: 6950797
• MDR Text Key: 89363466
• Report Number: 6950797
• Device Sequence Number: 1
• Product Code: DXO
• 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: 10/05/2017

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: Physician
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 10185
• 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: 10/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 55 YR