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

Model Number 25188

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

Patient Problem Pulmonary Embolism (1498)

Event Date 03/02/2021

Event Type  Death  

Manufacturer Narrative

It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.This medwatch is not to report a device malfunction, but to report an adverse patient effect.There was no report of a device malfunction during the procedure.Reference (b)(4).

Event Description

An angiodynamics clinical services manager reported a patient death, after procedure with an angiovac circuit.The following was reported: (b)(6) female with history of iv drug abuse who was in very poor health according to the physician was chosen for angiovac debulking of a large tricuspid valve vegetation that had both an atrial component and a sub-valvular component.During the initial procedure of using the angiovac device to remove vegetation from the tricuspid valve, the patient experienced a short period of low blood pressure and low oxygen levels.All of the material on the atrial side of the valve appeared to have been removed at this point and a large amount of material was visible in the bubble trap.The procedure was paused at the physician's direction and anesthesia treated the low blood pressure and low oxygen level with medication.The patient also required cardioversion for an atrial arrythmia.The blood pressure improved and the angiovac procedure was continued.The patient's oxygen level remained low and was in the mid 80% saturation range.Material on the ventricular side of the valve was then attempted to be removed.Numerous passes with the cannula on both the atrial and ventricular side of the valve were made.A wire was placed into the pa and was used to help guide the cannula towards the valve and help cross the valve, but the cannula was not advanced passed completely into the rv, only the funnel tip.The patient's condition did not change during this part of the procedure and the physician decided to end the angiovac part of the procedure with some of the well adhered vegetation still present in the rv.The blood in the circuit was returned to the patient and the access sheath and cannula were removed.The patient again required cardioversion for an atrial arrythmia, and oxygen saturation remained in the upper 80% range.Blood pressure was unchanged during this and had improved after the blood was returned to the patient.Physician broke scrub and we discussed the case in the control room.Around 10 minutes later i overheard that the patient was requiring cpr, so i went back into the control room.The physician had returned and was attempting to cannulate to place the patient on ecmo.The staff was overheard saying the patient was believed to have a pulmonary embolism.Efforts to cannulate for ecmo and cpr failed to revive the patient and she expired.There was no report of device malfunction or issue.It is believed that the patient's comorbidity and the procedure contributed to the event.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed due to the nature of this patient serious adverse event; there were no reports of angiovac device malfunction during the procedure.No sample was returned for evaluation.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.Labeling review: the angiovac cannula sample was not returned for evaluation since there was no reported device malfunction during the procedure.Directions for use 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 angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, CARDIOPULMONARY
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 11528414
• MDR Text Key: 241019195
• Report Number: 1317056-2021-00062
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251880
• UDI-Public: H965251880
• 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: 04/06/2021

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 Expiration Date: 02/28/2022
• Device Model Number: 25188
• Device Catalogue Number: 25194
• Device Lot Number: 5631962
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 32 YR