MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. SUPERSTIFF GUIDEWIRE; WIRE, GUIDE, CATHETER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); Cardiac Tamponade (2226)

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the left ventricle was perforated by a boston scientific super stiff guidewire, resulting in cardiac tamponade.The patient was placed on cardiopulmonary bypass and the perforation was surgically repaired.The patient was in stable condition post repair.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SUPERSTIFF GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 17525832
• MDR Text Key: 321067067
• Report Number: MW5132773
• Device Sequence Number: 1
• Product Code: DQX
• 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: 05/20/2013

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