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

Catalog Number	H965251860
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sudden Cardiac Death (2510)
Date of Event	02/16/2019
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: CATHETER, CANNULA & TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8367602
• Report Number: 1317056-2019-00042
• Device Sequence Number: 1620162
• Product Code: DWF
• UDI-Device Identifier: H965251860
• UDI-Public: H965251860
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K142593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: H965251860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2019
• Initial Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 42 YR