MAUDE Adverse Event Report: BOSTON SCIENTIFIC AMPLATZ SUPER STIFF GUIDEWIRE; WIRE, GUIDE, CATHETER

Device Problem Insufficient Information (3190)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Ventricular Fibrillation (2130); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

Medtronic received information that an amplatz super stiff guide wire caused a perforation and subsequent pericardial effusion during the implant of a transcatheter bioprosthetic aortic valve.Medications and cardiopulmonary resuscitation {cpr) were initiated for bradycardia, hypotension and ventricular fibrillation.The perforation was successfully repaired.No adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AMPLATZ SUPER STIFF GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17527756
• MDR Text Key: 321080293
• Report Number: MW5134687
• 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: 08/03/2016

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