MAUDE Adverse Event Report: LOMA VISTA MEDICAL TRUE DILATATION; BALLOON AORTIC VALVULOPLASTY

Catalog Number 02645-13

Device Problems Difficult to Remove (1528); Reset Problem (3019)

Patient Problem No Information (3190)

Event Date 11/20/2013

Event Type  No Answer Provided  

Event Description

Loma vista bard balloon true dilatation balloon could not be removed through the 14f sheath.The balloon did not fold properly after deflation.The sheath and balloon were both removed together while maintaining wire access.Another 14f sheath was placed.

• Brand Name: TRUE DILATATION
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): LOMA VISTA MEDICAL; 2201 san juan ave,; la juanta CO 81050
• MDR Report Key: 3691920
• MDR Text Key: 15107246
• Report Number: 3691920
• Device Sequence Number: 1
• Product Code: OZT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 01/13/2014

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?: *
• Device Operator: Physician
• Device Catalogue Number: 02645-13
• Device Lot Number: PLN 01298
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 107