MAUDE Adverse Event Report: BOSTON SCIENTIFIC SAFARI XS GUIDEWIRE; WIRE, GUIDE, CATHETER

Device Problem Patient-Device Incompatibility (2682)

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 safari xs guidewire perforated the left ventricle.It was reported that the perforation was a slit rather than a hole and the apex appeared to be torn due to friction with the wire.A pericardial effusion, cardiac tamponade and decreased blood pressure were reported.Cardiac massage was performed.The patient underwent open surgery with percutaneous cardiopulmonary support (pcps) to repair the perforation.It was reported that the intrinsic rate had been restored when the patient left the operating room and was weaning from pcps.The patient had a reported history of cardiomyopathy and left hemiparesis by stroke.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: SAFARI XS GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17529512
• MDR Text Key: 321131087
• Report Number: MW5136437
• 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: 04/18/2016

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