MAUDE Adverse Event Report: BOSTON SCIENTIFIC WIRE, GUIDE, CATHETER

Model Number SAFARI GUIDEWIRE

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Pericardial Effusion (3271)

Event Type  Death  

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve (b818246) pre-balloon aortic valvuloplasty (bav) was performed.Upon 80% deployment at 4mm on non-coronary cusp (ncc) and 5mm on left coronary cusp (lcc), hypotension occurred and angiography revealed the right coronary artery (rca) was occluded.The valve was recaptured and withdrawn from the body allowing the coronaries to fill.Echocardiogram revealed a pericardia i effusion attributed by the physician to the safari guidewire.A pericardia i tap was performed and the pressure did not recover.Ventricular tachycardia occurred and cardiopulmonary resuscitation (cpr) was performed.Subsequently, the patient expired.No autopsy was performed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: WIRE, GUIDE, CATHETER
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17528651
• MDR Text Key: 321039963
• Report Number: MW5135581
• 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: 02/28/2018

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
• Device Model Number: SAFARI GUIDEWIRE
• Patient Sequence Number: 1