MAUDE Adverse Event Report: ANGIODYNAMICS ANGIO VAC; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Device Problem Insufficient Information (3190)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/01/2018

Event Type  Death  

Event Description

Case reportedly required angiovac for vegetation on leads.No spectranetics devices were in use while the angiovac was in use to remove vegetation.During angiovac use, patient lost blood pressure and cpr was administered.Blood pressure was brought back; lead extraction then commenced and 4 leads were successfully extracted.After surgery, patient was on dialysis and died (b)(6) 2018.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ANGIO VAC
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS
• MDR Report Key: 17534756
• MDR Text Key: 321042187
• Report Number: MW5141656
• Device Sequence Number: 1
• Product Code: DWF
• 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: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1