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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve, a pericardial effusion was observed as a result of a perforation resulting from use of a boston scientific amplatz superstiff guidewire.The valve was deployed immediately and pericardiocentesis was performed to aspirate fluid from the pericardium.However, the patient's blood pressure could not be controlled, and the pericardial effusion resulted in cardiac tamponade.A mini-thoracotomy was performed to repair the small hole in the apex caused by the guidewire perforation.Intubation was weaned next day and the patient was reported in stable condition.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AMPLATZ SUPERSTIFF GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 17532516
• MDR Text Key: 321140595
• Report Number: MW5139424
• 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: 04/24/2013

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