MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / ANGIOVAC; CATHETER, CANNULA & TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number H965251860

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

Patient Problem Sudden Cardiac Death (2510)

Event Date 02/16/2019

Event Type  Death  

Manufacturer Narrative

As no lot number was reported, a ship history report (shr) was generated for item number (h965251860) in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The three lots obtained through the shr were (5398467, 5378568 and 5412623).The device history records for the lots obtained through the ship history report were reviewed.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the angiovac product family and the failure mode "patient injury/death." no adverse trend was identified.No sample was received for evaluation (device discarded at hospital).The event report states that event report states that, "the patient was stable during the entire procedure and immediately after, but coded upon arrival in the cvicu.Attempts to revive him were unsuccessful.The patient death is not related to the product." as stated in the directions for use supplied with the angiovac, regarding adverse events: "this device, as do all extracorporeal blood vessel devices, has possible side effects, which include but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques.These may occur if the instructions for use are not followed.Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, extracorporeal circulation and application of intravascular introducer systems which include but are not limited to: death; pulmonary embolism." ((b)(4)).

Event Description

As reported, "(b)(6) obese male patient came to the hospital with a saddle pe, thrombus into left pa as well as tumbling right atrial thrombus.Plan was to remove tumbling right atrial thrombus with angiovac.Surgery was not an option as his right ventricular strain was quite high and he wouldn't have survived open heart surgery according to the ct surgeon.The interventional cardiologist successfully aspirated over 40cm of thrombus and completed the case in the hope of minimizing additional clot burden on the lungs.The patient was stable during the entire procedure and immediately after, but coded upon arrival in the cvicu.Attempts to revive him were unsuccessful.The patient death is not related to the product (angiovac) at all." the device used during the procedure was discarded at the hospital.

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801
• MDR Report Key: 8367602
• MDR Text Key: 137059748
• Report Number: 1317056-2019-00042
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251860
• UDI-Public: H965251860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: H965251860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2019
• Initial Date FDA Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 42 YR