MAUDE Adverse Event Report: B. BRAUN Z-MED; BALLOON AORTIC VALVULOPLASTY

Device Problems Material Rupture (1546); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Medtronic received information that immediately following the implant of a transcatheter bioprosthetic valve, a 20 mm x 30 mm b.Braun z-med was inflated but then ruptured abruptly.When removing the balloon catheter, it was pulled back through the sheath with difficulty.It was determined that approximately 1/2 of the balloon was still attached to the catheter.An attempt was made to find the remainder of the balloon on angiography.The proximal balloon marker was located.Several attempts were made to capture the rest of the balloon and pull it out through the sheath.Eventually, the remainder of the balloon was caught and pulled into the sheath but the balloon became stuck inside the sheath.Subsequently, the balloon was removed together with the sheath and guidewire at once.The sheath was cut open to inspect the piece of balloon that had been captured and it was determined that all missing parts of the balloon had been successfully retrieved.No adverse patient effects were reported.702205946.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: Z-MED
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): B. BRAUN
• MDR Report Key: 17533233
• MDR Text Key: 321376411
• Report Number: MW5140137
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1