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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Perforation (2001)

Event Type  Death  

Event Description

Medtronic received information that during the implant of a medtronic transcatheter bioprosthetic valve, the boston scientific superstiff guidewire perforated the left ventricle.The perforation was not able to be repaired and the patient expired.No further information was provided.00063-c110 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: 17536157
• MDR Text Key: 321038273
• Report Number: MW5143047
• 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: 05/06/2013

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