MAUDE Adverse Event Report: ANGIODYNAMICS, INC ANGIOVAC CANNULA AND CIRCUIT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Type  Injury  

Event Description

In accordance with title 21 part 803, subpart b, 803.22(b)(2), this letter is to notify and provide you the information (b)(6) (a division of (b)(6)) received on 06 nov 2020 related to an alleged adverse event that occurred while an angiodynamics angiovac cannula and circuit were in use prior to the commencement of a lead extraction procedure.No (b)(6) medical devices were involved at the time that the angiovac was in use.Subsequent to this adverse event with use of the angiovac, (b)(6) devices were in use during the lead extraction procedure when a second adverse event occurred and the patient did not survive (please refer to mdr 1721279-2020-00242 which captures the adverse event in which (b)(6)devices were in use and an injury occurred).Patient information: 67 y/o male, dob (b)(6) 1952.3 leads being extracted due to a systemic infection.Multiple vegetation on leads noted pre-procedure.A lead extraction procedure was planned to remove right atrial (ra), right ventricular (rv) and left ventricular (lv) leads due to systemic infection.Multiple vegetations on leads were noted.Baseline intra-cardiac echocardiography (ice) was performed and confirmed vegetations.Prior to the lead extraction procedure beginning, an angiovac system was utilized from the patient's right internal jugular (ij) vein and right femoral vein.During the process of manipulating the wand in patient's inferior vena cava (ivc)/right atrium (ra), a large effusion presented on ice.The angiovac was stopped and a pericardiocentesis was performed and a drain was placed.As mentioned above, the lead extraction procedure itself and subsequent adverse event that occurred is captured in mor 1721279-2020-00242.(b)(6) is not the manufacturer nor importer of the abovementioned angiovac cannula and circuit.Angiodynamics is the manufacturer of this device.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ANGIOVAC CANNULA AND CIRCUIT
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS, INC
• MDR Report Key: 17523531
• MDR Text Key: 321088573
• Report Number: MW5130479
• 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: 01/14/2021

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