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

Model Number 25186

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

Patient Problem Death (1802)

Event Date 03/24/2020

Event Type  Death  

Manufacturer Narrative

It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.Complaint # (b)(4).

Event Description

It was reported that during an angiovac procedure for a patient with a history of intravascular metastatic cancer, material was observed to be mobile and near the right atrium (ra) and down in the inferior vena cava (ivc).The physician's plan was to go right femoral vein with the angiovac device and return cannula in the left femoral vein.Flows over 300 were not able to be achieved in the ivc.They passed wire and cannula up to ra, and flows were still unable to be achieved over a liter.They passed wire and cannula up to the svc, and again flows were under a liter.The surgical team started performing cardiopulmonary resuscitation (cpr) on the patient.They were able to get return of spontaneous circulation (rosc).The physician decided to go back on pump while in the right atrium.Material was seen in the filter and they were able to pull out on suction and get material on the surgical field from the angiovac cannula.Again, cpr was resumed.Then rosc was achieved, and they went back on pump.This was reported to have occurred a few more times, however, the physician pronounced the patient deceased in the operating room.The treating physician reported that there was no allegation of product deficiency or malfunction on or against the machine or any angiodynamics device(s).The physician reported that the event was due to the patient's medical condition, having "tumor like" material all throughout her vascular.The physician reported that they more than likely pushed material into the heart and obstructed the flow.The angiovac device is not available to be returned for physical evaluation.

Manufacturer Narrative

The angiovac device used during the event was not returned for evaluation as there was no reported device malfunction.The customer reported a serious adverse event (sae), i.E.Patient death, with the use of the angiovac device but there was no reported malfunction of the cannula or circuit during the procedure.No sample was returned for evaluation as there was no device malfunction.The root cause was determined to be related to the patient's health condition at the time of the procedure.Labeling review: the angiovac cannula sample was not returned for evaluation since there was no reported device malfunction during the procedure.Directions for use (dfu, 16600502-01) is provided with this device and contains the following statements: warnings: selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians' sole responsibility.The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique.The benefits of use of this device must be weighed against the risks including risks of systemic anticoagulation and must be assessed by the prescribing physician.As with all medical devices, this device and ancillary equipment are to be used by trained physicians only.Specifically, this device is to be used only by medical personnel experienced with initiating and monitoring extracorporeal bypass and by physicians trained and experienced using surgical and/or percutaneous (seldinger) vascular access techniques.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.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, VASCULAR,CARDIOPULMNARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• MDR Report Key: 9939845
• MDR Text Key: 187002495
• Report Number: 1317056-2020-00066
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251860
• UDI-Public: H965251860
• Combination Product (y/n): N
• PMA/PMN Number: K142593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

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 Model Number: 25186
• Device Catalogue Number: H965251860
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 34 YR