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

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513)

Event Type  Death  

Event Description

Medtronic received information that just prior to crossing the valve with the delivery catheter system (dcs), the patient felt chest pain.The blood pressure dropped and cpr was initiated.Transthoracic echocardiogram (tte) showed blood in the pericardium.150-200ml of blood was drained.It was suspected that the guide wire caused a perforation.It is unknown if an autopsy was performed.It was reported that an amplatz superstiff wire was deployed via a pigtail guiding catheter.The patient expired the day of the procedure.(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
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17525527
• MDR Text Key: 321038906
• Report Number: MW5132468
• 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: 05/01/2014

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