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

Catalog Number 10185

Device Problems Bent (1059); Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2015

Event Type  malfunction  

Event Description

Upon opening package it was noticed that the wire was bent/kinked.This occurred during set up, so no patient was affected.Another wire was used and worked fine (the package was discarded).

• Brand Name: VERRATA
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 klgore rd; rancho cordova CA 95670
• MDR Report Key: 5441042
• MDR Text Key: 38322373
• Report Number: 5441042
• 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: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2018
• 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: 11/16/2015
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES