MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC 25MM X 4CM X 130CM EDWARDS BALLOON CATHETER; BALLOON AORTIC VALVULOPLASTY

Model Number 9350BC25

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 09/19/2022

Event Type  malfunction  

Event Description

While using the edwards balloon catheter, while ballooning the balloon did rupture.It had been effective.The balloon appears to be intact.

• Brand Name: 25MM 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: 16310845
• MDR Text Key: 308921010
• Report Number: 16310845
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2023

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: Health Professional
• Device Model Number: 9350BC25
• Device Catalogue Number: 9350BC25
• Device Lot Number: 63628849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Male
• Patient Weight: 71 KG