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It was reported that a patient was to undergo an ablation procedure with a carto® 3 system.There was a surgical delay requiring administration of medication for a pacing issue.It was reported by the company representative that while preparing for a procedure, the error message "chest patch sensor error, replace patch unit" was displayed on the carto 3 system.To troubleshoot the chest patch cables were replaced, the issue was resolved, and the procedure was continued.It was reported, however, that while the physician was in the heart, with a 4mm catheter, they were unable to pace.To troubleshoot the company representative made sure the red and black cables were connected to the proper negative and positive electrodes and verified that they were okay in the ge block 31 and 32.It was confirmed that was correct on the carto 3 system, that the correct channel was chosen, and that everything was working with the ge recording system.They went on cardio lab blocks and everything was verified as being correct.The caller confirmed they could see the distal and proximal signals, but still could not pace.The medical team tried reseating the catheter to both the patient interface unit and checked the connection to the actual catheter handle without resolution.The staff started re-routing pacing through the ge recording system directly ( ge was plugged into bock a ).They could not see anything on the carto 3 system and still could not pace.The medical team temporarily discontinue the procedure and spent 2 hours troubleshooting.They attempted to repin all the catheters and cables without resolution.They eventually were able to pace by bypassing the carto 3 system.The staff was putting the patient's arms above their head and when doing so, and the company representative noticed that the patches had moved, however, it looked as though they were perfectly in place.The patches were not being visualized properly.The "learn new" message later appeared ( a message that typically appears when patches are displaced (red error)), but none were showing movement.The company rep tried changing out the pacing cables, a new ic out cable, and a new ecg out cable without resolution.Lastly, the company rep attempted to change out the io io 1 cable without resolution.The company representative previously wiped the workstation and reloaded the carto 3 system software.The further additional information was also provided: the pacing red and black cables were connected to the + and ¿ ports directly above the map port on the front of the piu.Staff never ablated during this case, so carto did not allow pacing from the map catheter ch.1-2 and ablating at the same time.Health care provider (hcp) did not attempt to pace and ablate at the same time, so reporter is unsure what would have happened if it been tried.The pacing stimulator is the ge cardialab system with the micropace.At first, this was a planned pacing to test to make sure hcp could pace before famming (fast anatomical mapping) or mapping.Then, when hcp could not pace (our test failed), staff began the troubleshooting period.During the 2 hours of troubleshooting, the patient went into svt multiple times, and hcp began trying to emergency pace.Hcp could not emergency pace, so the doctor had to give adenosine to break the tachycardia 2 different times reporter believes.In other instances during the troubleshooting period the patient went into supraventricular tachycardia (svt) but the svt broke spontaneously.Typically, hcp would pace the patient out of svt immediately for safety reasons.In this case, hcp were unable to do so.There was not unwanted pacing being delivered, because hcp could not pace at all during the troubleshooting period.The duration of the delay was about 2 hours of troubleshooting.Physician noted that the patient spent an extra 90 minutes under anesthesia during this period, which was identified to be unnecessary and dangerous (due to patient¿s age).Medication in the form of adenosine was required due to the delay.There have been no known patient complications other than unnecessary increased anesthesia time and not curing the svt.The adverse event was discovered during use of biosense webster products.Physician's opinion on the cause of this adverse event was bwi product inability to pace.Intervention was adenosine was given to break the tach.Outcome of the adverse event was fully recovered.Patient required extended hospitalization because of the adverse event because patient stayed the night for extra monitoring to be sure that the patient was in good condition.They never used the generator during this case.They have a brand new smartablate generator.Pec: pacing issue - emergency.Per form-1737 ¿ even though catheters are not intended for emergency pacing, the physician may choose to use the catheter to pace the heart when emergency pacing is needed.There is risk to patient if catheter is not able to pace during an emergency.Pec: c-3 location patch issue.Per form-1737 ¿ this is highly detectable.Most likely harm is procedure delay or cancellation.See procedural delay/cancellation.Pec: software bug pacing issue is mdr-reportable.C-3 location patch issue is not mdr-reportable.Software bug is not mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.
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The hardware investigation has begun but it has not been completed at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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On 6-jul-2023, the product investigation was completed.It was reported that a patient was to undergo an ablation procedure with a carto® 3 system.There was a surgical delay requiring administration of medication for a pacing issue.Device evaluation details: it was confirmed that the issue was resolved by replacing the faulty piu (patient interface unit)+lp with another one that was delivered to the customer.The issue was resolved.Replaced piu was sent to device manufacturer for investigation and repair.The customer complaint ¿unable to pace¿, was confirmed.The issue was caused by a defective component on the ecg card.Replacing the defective component on the ecg card solved the issue.This location pad s.N: (b)(4) arrived at sanmina lab along with the piu s.N: (b)(4), after investigation was determined as not a failure part.A manufacturing record evaluation was performed for the carto 3 system # 11678, and no internal actions related to the reported complaint condition were identified.The complaint investigation results will be used for monitoring and detecting statistical signals per complaint trending and signal detection process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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