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

Model Number 9350BC23

Device Problems Material Rupture (1546); Activation, Positioning or Separation Problem (2906)

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

Event Date 10/19/2017

Event Type  malfunction  

Event Description

During deployment of the edwards tavr valve the inflation balloon ruptured and the valve was unable to be deployed.

• 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: 7103926
• MDR Text Key: 94374489
• Report Number: 7103926
• 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: Other
• Type of Report: Initial
• Report Date: 10/31/2017,11/29/2017

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: No Information
• Device Model Number: 9350BC23
• Device Catalogue Number: 9350BC23A
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR