Model Number M004CRBS3050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982); ST Segment Elevation (2059); Weakness (2145)
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Event Date 09/10/2020 |
Event Type
Injury
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Event Description
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It was reported that during a pulmonary vein isolation (pvi) cryoablation procedure, they had successfully ablated three veins.When they were ablating the last vein (right superior pulmonary vein (rspv)), the physician stopped the ablation due to no effect using a single stop.After the polarx balloon deflated, they observed a small st segment elevation (2mv).The elevation lasted for a minute, and during that minute, after about 30 seconds they got error 1 - 00004000-2: console detected blood in catheter.They immediately pulled out the catheter and found blood inside of the balloon catheter.The blood also got into the cryo gas cable.They exchanged the polarx balloon catheter and the cryo gas cable, and tried again.The exact same problem recurred.This time, the st segment elevation (2mv) lasted for only 30 seconds.They then decided to exchange the polarx balloon catheter, the polarsheath, the polarmap mapping catheter and the cryo gas cable.Afterwards, they were able to ablate the rspv without any further issues and completed the case.The patient was fine when he left the laboratory, without any further events.Six hours after the case, the physician reported that the patient experienced a stroke and that he was being medicated.The patient's status pending.The products are expected to be returned for analysis.
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Event Description
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It was reported that during a pulmonary vein isolation (pvi) cryoablation procedure, they had successfully ablated three veins.When they were ablating the last vein (right superior pulmonary vein (rspv)), the physician stopped the ablation due to no effect using a single stop.After the polarx balloon deflated, they observed a small st segment elevation (2mv).The elevation lasted for a minute, and during that minute, after about 30 seconds they got error 1 - 00004000-2: console detected blood in catheter.They immediately pulled out the catheter and found blood inside of the balloon catheter.The blood also got into the cryo gas cable.They exchanged the polarx balloon catheter and the cryo gas cable, and tried again.The exact same problem recurred.This time, the st segment elevation (2mv) lasted for only 30 seconds.They then decided to exchange the polarx balloon catheter, the polarsheath, the polarmap mapping catheter and the cryo gas cable.Afterwards, they were able to ablate the rspv without any further issues and completed the case.The patient was fine when he left the laboratory, without any further events.Six hours after the case, the physician reported that the patient experienced a stroke and that he was being medicated.The patient's status pending.The products are expected to be returned for analysis.It was further reported that the first blood detection happened at the last out of four veins approximately 40 minutes after the puncture.After the transseptal puncture, the activated clotting time (act) was >300 seconds at all times throughout the procedure.The pulmonary veins were sequentially isolated finishing with right superior.The balloon was positioned and was occlusive of right superior vein but after 100 seconds of freeze no electrical isolation was achieved.Therefore, the freeze was stopped and thaw occurred.At the time of deflating, a small st segment elevation of approximately 2 mv was noted in leads ii, iii and avf.The patient was awake with conscious sedation throughout and at this stage was well with no complaints.Phrenic nerve integrity was monitored by patient breathing and interaction with the patient.After one minute, the st segment elevation recovered and everything was normal but then the console system showed blood detection in the balloon.At this point, the procedure was stopped and the balloon taken out.The balloon was seen to be "absolutely full" of blood which was thought to be in the inner lumen and not between the balloons.The sheath had been left in the patient and there was no manipulation during the events.The second balloon was then inserted and again the procedure repeated to attempt isolation of vein but after 120 seconds of freeze there was no electrical isolation.The same sequence of events occurred with st segment elevation occurring for about 30 seconds commencing during thaw.There was no apparent patient harm.The console again showed the internal blood error.The catheter was removed and there was blood again in the inner lumen (it is thought).This was evaluated by putting the balloon in a water bath.There was not as much blood as before, but it was still quite a lot.The whole system was removed including the sheath, and then using the same transeptal puncture as a guide wire was left in place, another sheath was tracked into left atrium and a third catheter used to isolate the vein with good occlusion and normal function of the system throughout.Throughout this time, the patient was awake and orientated although having fentanyl.Having completed the procedure, the catheters were removed and pressure was put on to the groin wound as is normal practice.This required that the patient cooperates by lifting their back in order to allow bandaging to be placed over the puncture site and it was noted that the patient was weak on the left side.He could lift his left leg, but with some difficulty.A quick neurological examination showed reduced power both in left arm and left leg although he could lift his arms above his head and was awake and orientated in place and time.Half an hour after the procedure, the patient began to deteriorate further with less power on the left side and this progressed through the next 24 hours.The neurological deterioration was slowly progressive and unusual for an embolic event.A computed tomography (ct) angiogram showed some loss of intensity on the right side suggesting an ischemic event.The senior neurologist conducting examinations was not convinced that this was an embolic event for reasons related to his clinical assessment and wondered whether this may have been a contrast dye reaction given the curious slow evolution of the neurological deficits.An attempt was made to perform a magnetic resonance imaging (mri), but it was cancelled because the patient was moving too much.A mri scan was performed the following day, and showed a peripheral ischemic lesion on the right side.In the week following the procedure, the patient made a very good recovery and was able to walk almost normally and was talking normally.There was no abnormality noted with either the sheath or guide wire by the operator.It was then reported that there might be a second explanation for the patient's stroke.The non-boston scientific irrigation pump used in this case for the irrigation of the sheath seemed to have had problems with undetected bubbles.So, the cause for the stroke could be either the polarx cryoablation system or the irrigation pump.
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Event Description
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It was reported that during a pulmonary vein isolation (pvi) cryoablation procedure, they had successfully ablated three veins.When they were ablating the last vein (right superior pulmonary vein (rspv)), the physician stopped the ablation due to no effect using a single stop.After the polarx balloon deflated, they observed a small st segment elevation (2mv).The elevation lasted for a minute, and during that minute, after about 30 seconds they got error 1 - 00004000-2: console detected blood in catheter.They immediately pulled out the catheter and found blood inside of the balloon catheter.The blood also got into the cryo gas cable.They exchanged the polarx balloon catheter and the cryo gas cable, and tried again.The exact same problem recurred.This time, the st segment elevation (2mv) lasted for only 30 seconds.They then decided to exchange the polarx balloon catheter, the polarsheath, the polarmap mapping catheter and the cryo gas cable.Afterwards, they were able to ablate the rspv without any further issues and completed the case.The patient was fine when he left the laboratory, without any further events.Six hours after the case, the physician reported that the patient experienced a stroke and that he was being medicated.The patient's status pending.The products are expected to be returned for analysis.It was further reported that the first blood detection happened at the last out of four veins approximately 40 minutes after the puncture.After the transseptal puncture, the activated clotting time (act) was >300 seconds at all times throughout the procedure.The pulmonary veins were sequentially isolated finishing with right superior.The balloon was positioned and was occlusive of right superior vein but after 100 seconds of freeze no electrical isolation was achieved.Therefore, the freeze was stopped and thaw occurred.At the time of deflating, a small st segment elevation of approximately 2 mv was noted in leads ii, iii and avf.The patient was awake with conscious sedation throughout and at this stage was well with no complaints.Phrenic nerve integrity was monitored by patient breathing and interaction with the patient.After one minute, the st segment elevation recovered and everything was normal but then the console system showed blood detection in the balloon.At this point, the procedure was stopped and the balloon taken out.The balloon was seen to be "absolutely full" of blood which was thought to be in the inner lumen and not between the balloons.The sheath had been left in the patient and there was no manipulation during the events.The second balloon was then inserted and again the procedure repeated to attempt isolation of vein but after 120 seconds of freeze there was no electrical isolation.The same sequence of events occurred with st segment elevation occurring for about 30 seconds commencing during thaw.There was no apparent patient harm.The console again showed the internal blood error.The catheter was removed and there was blood again in the inner lumen (it is thought).This was evaluated by putting the balloon in a water bath.There was not as much blood as before, but it was still quite a lot.The whole system was removed including the sheath, and then using the same transeptal puncture as a guide wire was left in place, another sheath was tracked into left atrium and a third catheter used to isolate the vein with good occlusion and normal function of the system throughout.Throughout this time, the patient was awake and orientated although having fentanyl.Having completed the procedure, the catheters were removed and pressure was put on to the groin wound as is normal practice.This required that the patient cooperates by lifting their back in order to allow bandaging to be placed over the puncture site and it was noted that the patient was weak on the left side.He could lift his left leg, but with some difficulty.A quick neurological examination showed reduced power both in left arm and left leg although he could lift his arms above his head and was awake and orientated in place and time.Half an hour after the procedure, the patient began to deteriorate further with less power on the left side and this progressed through the next 24 hours.The neurological deterioration was slowly progressive and unusual for an embolic event.A computed tomography (ct) angiogram showed some loss of intensity on the right side suggesting an ischemic event.The senior neurologist conducting examinations was not convinced that this was an embolic event for reasons related to his clinical assessment and wondered whether this may have been a contrast dye reaction given the curious slow evolution of the neurological deficits.An attempt was made to perform a magnetic resonance imaging (mri), but it was cancelled because the patient was moving too much.A mri scan was performed the following day, and showed a peripheral ischemic lesion on the right side.In the week following the procedure, the patient made a very good recovery and was able to walk almost normally and was talking normally.There was no abnormality noted with either the sheath or guide wire by the operator.It was then reported that there might be a second explanation for the patient's stroke.The non-boston scientific irrigation pump used in this case for the irrigation of the sheath seemed to have had problems with undetected bubbles.So, the cause for the stroke could be either the polarx cryoablation system or the irrigation pump.
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Manufacturer Narrative
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The product was returned to boston scientific for analysis.Visual, microscopic and x-ray inspections were performed and no abnormalities of the distal tip, hemostatic valve, or flushing line were noted.X-ray review of the articulation region and shaft showed no abnormalities in the braid, shaft integrity or steering system.Functional testing was then performed.The sheath steering performance was evaluated, and the sheath was capable of the full range of steering motion.In addition, the straight/un-stressed neutral steering position was normal, and there were no signs of kinking damage.Air pressure testing was performed to identify the location of any potential leaks.The device was gently pressurized at the flushing line luer fitting while plugging the distal tip of the catheter; the measurements were within the acceptable range.Laboratory analysis did not identify any characteristics of the polarsheath that would have caused or contributed to the reported clinical observations.No leaks were identified during testing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
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