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

Device Problem Malposition of Device (2616)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve, a boston scientific super stiff guidewire caused a perforation.It was reported that the curve of the guidewire tip was in the myocardium instead of the left ventricle while a pre-implant balloon aortic valvuloplasty (bav) balloon was placed across the annulus.A decrease in blood pressure was noted.Cardiopulmonary resuscitation (cpr) was initiated and an echocardiogram showed pericardial effusion due to the perforation.Pericardial tamponade was noted at the inferior part of the left ventricle.A sternotomy was performed to repair the perforation surgically.The patient was reported to be recovering well after the procedure.No further 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: 17534036
• MDR Text Key: 321136355
• Report Number: MW5140939
• 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: 02/04/2016

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