MAUDE Adverse Event Report: BRAUN / NUMED, INC. Z-MED BALLOON VALVULOPLASTY CATH; BALLOON AORTIC VALVULOPLASTY

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Condition a ctb.Ruptured balloon.Fda safety report id # (b)(4).

• Brand Name: Z-MED BALLOON VALVULOPLASTY CATH
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): BRAUN / NUMED, INC. ; bethlehem PA 18018
• MDR Report Key: 12590040
• MDR Text Key: 275950851
• Report Number: MW5104451
• Device Sequence Number: 1
• Product Code: OZT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/04/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR