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 Problems Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Ventricular Tachycardia (2132)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

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.As the device was not returned, angiodynamics was unable to perform a device evaluation.Without a device evaluation, a root cause for the reported complaint cannot be determined.The customer's reported complaint description cannot be confirmed due to the nature of this patient adverse event; there were no reports of angiovac device malfunction during the procedure.No sample was returned for evaluation.No device history report review was conducted since there was no reported lot number and ship history lot review was not performed since item number is unknown.The cardiac arrhythmia issues that occurred during the procedure is an anticipated procedural complication of the angiovac procedure.It was also cautioned to the doctor that this would likely not be a successful angiovac case given the location of the mass.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 (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, arrhythmias, damage to vessel, ventricular perforation.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).This follow up mdr report is also a correction to the registration number filed on the initial mdr submission.The initial mdr was filed under 1317056-2020-00002.There was a typo in the number, it should have been 1317056-2020-00027.All information in the initial mdr is correct, but has been duplicated in this report in order to capture all event information.

Event Description

As reported: angiovac (av, generation 2) case with material in the rv.Adhered to the wall.Non mobile.Almost obstructing the rvot.No pre-case planning or images were reviewed before the procedure.Both surgeon and i were unavailable to pre-case plan.I received a text late the night before on new years day about the case and it was scheduled for first thing in the morning.This was the doctors second/third case.Patient has a history of cancer along with other comorbidities.Previous surgeries - cabg x4 (18 years ago) (b)(6) male.The patient did not want to have open heart surgery again.Once tee probe was inserted we discussed the case.His goal was to debulk as much as possible.I explained the difficulties of the case with concerns about crossing the valve and set expectations low for the procedure due to the appearance and location of the mass that it would not be likely that this would be a successful case.Surgeon discussed his plan for the case which was to place a wire across the tricuspid valve, through the rvot and into the pa and go on pump in the rv to get out as much material as possible.Access points were 26f gds sheath through the rij and return in the lfv.Access was gained, small sheaths were placed and heparin was given.Lfv small sheath was upsized to a 17fr return and wet to wet connections to our circuit which was primed and lines were separated.Rij was upsized to a 26fr gds.Soft wire into the pa through the gds.Jr4 diagnostic cath was placed, soft wire removed and stiff lunderquist (260cm) was placed through the jr4 and into the pa.Suture was also placed into one pedal, distal tip of the av closest to the inside aspect of the 20 degree angle for steerability.Av device was then placed over the wire into the rv.Obturator was taken out but wire stayed in during the procedure.Flows were between 1.5-2.5l.Angiovac was advanced to the material and the material was engaged.No material visualized in the tubing or in the bubble trap.During this time the patients blood pressure dropped, pt had a few brief moments of vtach, as well as bradycardia.They came off pump a few times because of this.The next move was to take av out and place av with obturator all the way up into the pa take obturator out, go on pump and slowly walk the av back from pa, rvot to rv and debulk the mass that way.Wire remained in at all times.At this time patients blood pressure dropped, brief moments of vtach and bradycardia.No material was removed after the aforementioned repositioning of the cannula.They decided to go back in one more time.Av was placed through the tv over the wire a third time and again patients blood pressure dropped and became bradycardic.At this point the patient coded.Cpr was started and meds were given.After 10 mins the finally got the patient back.Tee now showed a torn cord.Material was still in the rv and they decided to end the procedure.It was reported the defective disposable device is not available for return to the manufacturer.

• Brand Name: ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, VASCULAR,CARDIOPULMNARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, ny ; 7424488
• MDR Report Key: 9701008
• MDR Text Key: 192405287
• Report Number: 1317056-2020-00027
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25186
• Device Catalogue Number: H965251860
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR