MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC 23MM X 4CM X 130CM EDWARDS BALLOON CATHETER; BALLOON AORTIC VALVULOPLASTY

Model Number 9350BC23

Device Problems Positioning Failure (1158); Material Rupture (1546)

Patient Problem Tissue Damage (2104)

Event Date 10/23/2015

Event Type  malfunction  

Event Description

During deployment of the edwards tavr valve the inflation balloon ruptured and valve was unable to be deployed - although it did expand enough to prevent the valve to be retracted back in the delivery sheath - the valve was ultimately removed from the access site of the lt subclavian artery with a cut down and patch grafting needed.

• Brand Name: 23MM X 4CM X 130CM EDWARDS BALLOON CATHETER
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 6995835
• MDR Text Key: 90878077
• Report Number: 6995835
• Device Sequence Number: 1
• Product Code: OZT
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/25/2017

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 Model Number: 9350BC23
• Device Catalogue Number: 9350BC23A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR