MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH

Model Number M004CRBS3050

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Muscle Spasm(s) (1966); Muscle Weakness (1967); ST Segment Elevation (2059); Loss of consciousness (2418); Cognitive Changes (2551); Complete Heart Block (2627); Convulsion/Seizure (4406); Heart Block (4444); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during a cryoablation procedure to treat paroxysmal atrial fibrillation with a polarsheath, after removing the dilator from the sheath in the left atrium (la), blood was aspirated (16cc) and followed by air.The air origin was not clear (sheath valve or 3-way stopcock).While inserting the polarsheath into the left atrium, the dilator was removed as usual, as slowly as possible.Once removed, blood was aspirated with a syringe.At first, this was normal, but after around 16cc of blood, air followed.The 3-way stopcock was closed.However additional air entered into the system subsequently and within 1 second, no more blood could be seen in the tube connecting the sheath handle to the stopcock.The 3-way stopcock was opened again to aspirate the air.They at first aspirated 30cc of air, before blood again was aspirated without additional appearance of air.A flush line was connected as usual.St segment elevations started to occur, and the physician started mitigation acts: trendelenburg tilting the table, ventricular pacing in anticipation of av-block that subsequently also did occur and in order to advance the air through the coronaries as quickly as possible.On fluoroscopy, air was suspected in the aortic root.A pigtail catheter was advanced retrogradely into the aortic root in order to attempt to aspirate the air.However, once the pigtail was in the aortic root, most of the air could no longer be seen.Coronary angiography of the coronary artery (rca) was performed, and the vessel was open without detectable air.The patient was hemodynamically stable with volume supplementation at any time.Both the av-block as well as the st-elevations resolved within about 15 minutes.At that point in time, the decision was taken to pursue the cryoablation in this clearly symptomatic patient, which was successfully completed uneventfully in less than 30 minutes.On awaking from the propofol sedation, the patient had spastic extremities and a hemisyndrome on the left side.She was able to talk and was fully oriented.A computed tomography (ct) scan was performed and showed diffuse hypoperfusion of the right hemisphere.As per neuroradiology and neurology, those changes were indicative of a post-seizure state.Anti-seizure treatment was started.Over the course of the next five hours, the patient's neurological state deteriorated.The patient experienced an air embolism and was hemineglect.An electroencephalogram (eeg) ruled out a potential seizure, which was a potential diagnostic of the ct scan.Cerebral magnetic resonance imaging (mri) did not show signs of a stroke nor ischemia or bleeding.The patient was intubated.No vascular obstruction was seen.A delayed perfusion of the right hemisphere was seen.As per neuroradiology and neurology, those changes were still more compatible with a post-seizure state than with a stroke.Twelve hours later, the patient was still intubated.Despite stopping the sedation, she had not woken up, but was spontaneously breathing.Three days post procedure, the patient woke up and was talking, oriented and moving both arms and legs.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Correction: added patient code convulsion/seizure e0109.

Event Description

It was reported that during a cryoablation procedure to treat paroxysmal atrial fibrillation with a polarsheath, after removing the dilator from the sheath in the left atrium (la), blood was aspirated (16cc) and followed by air.The air origin was not clear (sheath valve or 3-way stopcock).While inserting the polarsheath into the left atrium, the dilator was removed as usual, as slowly as possible.Once removed, blood was aspirated with a syringe.At first, this was normal, but after around 16cc of blood, air followed.The 3-way stopcock was closed.However additional air entered into the system subsequently and within 1 second, no more blood could be seen in the tube connecting the sheath handle to the stopcock.The 3-way stopcock was opened again to aspirate the air.They at first aspirated 30cc of air, before blood again was aspirated without additional appearance of air.A flush line was connected as usual.St segment elevations started to occur, and the physician started mitigation acts: trendelenburg tilting the table, ventricular pacing in anticipation of av-block that subsequently also did occur and in order to advance the air through the coronaries as quickly as possible.On fluoroscopy, air was suspected in the aortic root.A pigtail catheter was advanced retrogradely into the aortic root in order to attempt to aspirate the air.However, once the pigtail was in the aortic root, most of the air could no longer be seen.Coronary angiography of the coronary artery (rca) was performed, and the vessel was open without detectable air.The patient was hemodynamically stable with volume supplementation at any time.Both the av-block as well as the st-elevations resolved within about 15 minutes.At that point in time, the decision was taken to pursue the cryoablation in this clearly symptomatic patient, which was successfully completed uneventfully in less than 30 minutes.On awaking from the propofol sedation, the patient had spastic extremities and a hemisyndrome on the left side.She was able to talk and was fully oriented.A computed tomography (ct) scan was performed and showed diffuse hypoperfusion of the right hemisphere.As per neuroradiology and neurology, those changes were indicative of a post-seizure state.Anti-seizure treatment was started.Over the course of the next five hours, the patient's neurological state deteriorated.The patient experienced an air embolism and was hemineglect.An electroencephalogram (eeg) ruled out a potential seizure, which was a potential diagnostic of the ct scan.Cerebral magnetic resonance imaging (mri) did not show signs of a stroke nor ischemia or bleeding.The patient was intubated.No vascular obstruction was seen.A delayed perfusion of the right hemisphere was seen.As per neuroradiology and neurology, those changes were still more compatible with a post-seizure state than with a stroke.Twelve hours later, the patient was still intubated.Despite stopping the sedation, she had not woken up, but was spontaneously breathing.Three days post procedure, the patient woke up and was talking, oriented and moving both arms and legs.It was further reported that the physician was quite happy with performance of the system to date and had no complaints alleging the sheath was faulty, and there was no allegation that this had anything to do with the balloon catheter as the sequence of events involving air happened prior to introduction of the balloon.The amount of air aspirated indicates either an unrecognized "open to air" situation of a stop cock/line connection, or inadvertent air injection (not likely to be the case here).Of note, the physician did reflect on his practice after discussion with colleagues in that he doesn't routinely level the sheath at or below the level of the la.May have exacerbated the pressure gradient but in itself unlikely to have added to the issue.Sheath prep and access were all according to our instructions and no complications were encountered.A mri scan was done 24 hours after the event and neuroradiological read indicated findings most consistent with seizure, but no evidence of infarct.The patient has fully recovered.The patient went to neurology rehabilitation.She has had a spectacular and almost complete recovery with only minimal residual symptoms (minimal instability when walking).The physician had no problem in getting the sheath/dilator guide wire into la.He slowly withdrew the dilator and wire.He then aspirated, and after approximately 15ml of blood, there was air in the system.He thought he was certain of closure of the three way tap.He then undertook a series of maneuvers to try to get air out and sort the system out.It was difficult to understand the choreography.He reopened the three way stop cock to aspirate and got a further 30mls of air out (using a 20ml syringe).From the sheath aspirated a further 30-40ml of air.In addition, he prepared for coronary embolism by putting in a pacing wire.There was st shift and patient needed pacing (av block and hypotensive at 60/40mmhg.).On fluoroscopy there was air in the aortic root and he then tried to aspirate that but all the air had gone by the time a catheter introduced.Qrs was again normal and patient was now hemodynamically stable.At that stage, there was no further air ingress that he could determine and the patient was stable, and so he decided to proceed with the pulmonary vein isolation (pvi) as the patient had already been exposed to intervention and he felt the balance of risk was in favor of performing the procedure.He did not have the sheath positioned at the correct level in such a way as to prevent air ingress due to la hemodynamics.All air ingress was before introduction of the balloon and just during catheter prep.The patient's neurology was difficult to understand.She was talking and orientated with some left sided weakness.She had a series of ictal events.Ct scanning showed hypoperfusion, but together with mri was interpreted as post ictal change.The day following the procedure become more obtund and then made complete recovery so delayed neurological consequences that are unexplained.

Manufacturer Narrative

The device was returned to boston scientific for analysis.The unit was received for analysis after decontamination in sterilizer pouch.The dilator was returned inserted inside the entire length of the sheath.Return of the dilator within the sheath valve may contribute to valve damage and poor valve performance.Functional testing (prior to dilator removal) was performed.The device was air pressure decay leak tested prior to removing the dilator.The distal end of the device was sealed by squeezing the distal end of the sheath shaft against the dilator using a touhy-borst seal.The distal end of the device was determined to be leak free by submerging underwater while the device was pressurized to 6 psi.The device passed the test with a decay of 0.0241 psi with the dilator in place.The device was then subjected to hemostasis valve test method.The device passed the test; no drips of water formed or fell from the valve during the 30 second test.The device was soaked in warm water and irrigated at 5 ml/min through the flushing line for 3 hours to promote gentle removal of the dilator.The dilator was then removed gently from the length of the sheath.No abnormal jarring or jerking was observed during removal.The valve was inspected following dilator removal.Two significant tears in the outer surface were identified.Functional testing (after dilator removal) was then performed.With the dilator removed, the air pressure decay leak test as described previously was re-performed.Again, prior to testing, the distal end of the device was determined to be leak free by submerging underwater while the device was pressurized to 6 psi.The device failed the leak test with a gross leak condition within the first few seconds of testing.When pressurized, with the valve end of the device was submerged underwater and air bubbles release from the valve slits.The device was then subjected to hemostasis valve test method.The device failed the test; drips of water formed and fell from the valve within 10 seconds.Finally, the device was subjected to aspiration test method.The device passed the test; no air was drawn into the 10 ml test syringe during aspiration of the flushing line.The dilator was reviewed for any abnormalities.The distal end of the dilator showed no signs of bending or other damage.The shaft along the length of the dilator also showed no signs of abnormalities.The proximal end of the dilator has a small protrusion running lengthwise near the bond between the white polymer hub and the blue shaft.This is a secondary observation and is not anticipated to have contributed to the complaint condition.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that during a cryoablation procedure to treat paroxysmal atrial fibrillation with a polarsheath, after removing the dilator from the sheath in the left atrium (la), blood was aspirated (16cc) and followed by air.The air origin was not clear (sheath valve or 3-way stopcock).While inserting the polarsheath into the left atrium, the dilator was removed as usual, as slowly as possible.Once removed, blood was aspirated with a syringe.At first, this was normal, but after around 16cc of blood, air followed.The 3-way stopcock was closed.However additional air entered into the system subsequently and within 1 second, no more blood could be seen in the tube connecting the sheath handle to the stopcock.The 3-way stopcock was opened again to aspirate the air.They at first aspirated 30cc of air, before blood again was aspirated without additional appearance of air.A flush line was connected as usual.St segment elevations started to occur, and the physician started mitigation acts: trendelenburg tilting the table, ventricular pacing in anticipation of av-block that subsequently also did occur and in order to advance the air through the coronaries as quickly as possible.On fluoroscopy, air was suspected in the aortic root.A pigtail catheter was advanced retrogradely into the aortic root in order to attempt to aspirate the air.However, once the pigtail was in the aortic root, most of the air could no longer be seen.Coronary angiography of the coronary artery (rca) was performed, and the vessel was open without detectable air.The patient was hemodynamically stable with volume supplementation at any time.Both the av-block as well as the st-elevations resolved within about 15 minutes.At that point in time, the decision was taken to pursue the cryoablation in this clearly symptomatic patient, which was successfully completed uneventfully in less than 30 minutes.On awaking from the propofol sedation, the patient had spastic extremities and a hemisyndrome on the left side.She was able to talk and was fully oriented.A computed tomography (ct) scan was performed and showed diffuse hypoperfusion of the right hemisphere.As per neuroradiology and neurology, those changes were indicative of a post-seizure state.Anti-seizure treatment was started.Over the course of the next five hours, the patient's neurological state deteriorated.The patient experienced an air embolism and was hemineglect.An electroencephalogram (eeg) ruled out a potential seizure, which was a potential diagnostic of the ct scan.Cerebral magnetic resonance imaging (mri) did not show signs of a stroke nor ischemia or bleeding.The patient was intubated.No vascular obstruction was seen.A delayed perfusion of the right hemisphere was seen.As per neuroradiology and neurology, those changes were still more compatible with a post-seizure state than with a stroke.Twelve hours later, the patient was still intubated.Despite stopping the sedation, she had not woken up, but was spontaneously breathing.Three days post procedure, the patient woke up and was talking, oriented and moving both arms and legs.Additional information was received on both the sequence of events that occurred during the procedure and the physician's experience with the polarsheath.The physician was satisfied with performance of the system and had no allegations against the functionality of the sheath.There were no allegations against the balloon catheter as the air ingress was before introduction of the balloon while the sheath was being prepared.Sheath preparation and access were all performed according to the instructions for use and no complications were encountered.The physician did not experience any difficulties getting the sheath/dilator guide wire into the left atrium (la).He slowly withdrew the dilator and wire.He then aspirated, and after approximately 15ml of blood, there was air in the system.He thought he was certain of closure of the three-way stopcock.He then undertook a series of maneuvers to try to remove the air and resolve the issue.The physician reopened the three way stop cock to aspirate and removed 30mls of air (using a 20ml syringe); a total of 30-40ml of air was aspirated through the sheath.In addition, he prepared for coronary embolism by putting in a pacing wire.There was an st shift and patient needed pacing (av block and hypotensive at 60/40mmhg.).On fluoroscopy, air was visible in the aortic root.The physician attempted to aspirate, but the air was gone by the time a catheter was introduced.The patient's qrs complex returned to normal and the patient was hemodynamically stable.As no further air ingress was observed and the patient was stable, the physician elected to complete the pulmonary vein isolation (pvi) as the patient had already been exposed to intervention and felt the balance of risk was in favor of performing the procedure.Further physician discussions noted that the amount of air aspirated indicates either an unrecognized "open to air" situation of a stop cock/line connection, or an inadvertent air injection (not likely to be the case here).Of note, the physician did reflect on his practice after discussion with colleagues in that he doesn't routinely level the sheath at or below the level of the left atrium which can exacerbate the pressure gradient.It was indicated that that the sheath was possibly not positioned at the correct level in such a way as to prevent air ingress due to la hemodynamics.Following the procedure, the patient was talking and orientated with some left sided weakness and then experienced a series of seizures.A ct scan showed hypoperfusion; an mri scan was performed and indicated findings consistent with seizure, but no evidence of an infarct.The patient has almost completely recovered with only minimal residual symptoms (minimal instability when walking).

• Brand Name: POLARSHEATH
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• MDR Report Key: 11240011
• MDR Text Key: 229079552
• Report Number: 2134265-2021-00894
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0026053429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 03/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention