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| Model Number FG540000 |
| Device Problems
Signal Artifact/Noise (1036); Electrical Shorting (2926); Patient Device Interaction Problem (4001)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 05/27/2021 |
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Event Type
Injury
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Manufacturer Narrative
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The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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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Event Description
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It was reported that a patient underwent an idiopathic ventricular tachycardia (vt) ablation procedure with a carto® 3 system.The patient required prolonged hospitalization because the procedure was cancelled.The patient¿s medical history is ¿icd implanted¿.The carto® 3 system displayed error 7, "current leakage error," during ablation, and simultaneously all of the body surface and ecg signals were "washed out" on the carto® 3 system and recording system.The catheter cable was replaced twice, without resolution.The catheter was replaced, without resolution.The cable was replaced a third time, without resolution.The grounding pad was replaced without resolution.The catheter was replaced a second time, still without resolution.The biosense webster, inc.Representative noted that they were on the phone with the biosense webster, inc.Field representative while troubleshooting the issue.The procedure was canceled as the issue could not be resolved.After the procedure had been canceled, the biosense webster, inc.Representative performed a preventative maintenance on the carto® 3 system (with the biosense webster, inc.Field representative still on the phone) and confirmed that the carto® 3 system is operating per specifications.The reporter stated that it is still undetermined what caused the issue.Additional information was received on the event.No harm/complication occurred other than cancelled procedure.This adverse event discovered during use of biosense webster, inc.Products.The physician¿s opinion on the cause of this adverse event was biosense webster, inc.Product malfunction related and the cancellation of the procedure did not contribute to a death or a serious injury to the patient.Case cancelled and rescheduled after preventative maintenance could be performed.Patient outcome was reported as fully recovered (no residual effects).The patient required extended hospitalization because of the adverse event as the patient was flown in from another island and required this ablation before discharge and flight back home.The patient was under general anesthesia for 4 hours.Patient was flown in from another island and goes into incessant vt which requires ablation.A transseptal puncture was not performed prior to the case cancellation.The signal interference (noise) was observed on the intracardiac, body surface or all ecg (bs + ic) channels.The physician did not have any intact ecg signal available to monitor the patient¿s heart rhythm.Radio frequency ablation washed out all other monitor devices as well (anesthesia monitor and defibrillator).The catheter was in the patient¿s body during the signal interference.In addition, an expired cable was used in the troubleshooting of this procedure as a last effort.This was not a product inserted into the patient.A sterile sleeve was used over the expired cable where it would have had contact with sterile field.The product was received at the facility prior to the expiration date.The product expired during storage.The absence of treatment was assessed as serious and mdr reportable under the carto® 3 system since the event required prolonged hospitalization.The signal interference (noise) issue was assessed as a reportable mdr malfunction under the carto® 3 system since there was no ecg signal available to monitor the patient¿s heart rhythm.The current leakage error was assessed as not mdr reportable.This issue was highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety was unaffected by this issue.The expired product issue for the cable was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.
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Manufacturer Narrative
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If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 6/25/2021, noted a correction to the 3500a initial as ¿b1.Is product problem¿ was not checked.Therefore, have processed this field.
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Manufacturer Narrative
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The investigation was completed on 26-jul-2021.It was reported that a patient underwent an idiopathic ventricular tachycardia (vt) ablation procedure with a carto® 3 system.The patient required prolonged hospitalization because the procedure was cancelled.It was reported that the carto® 3 system displayed error 7, "current leakage error," during ablation, and simultaneously all of the body surface and ecg signals were "washed out" on the carto® 3 system and recording system.The physician did not have any intact ecg signal available to monitor the patient¿s heart rhythm.The catheter cables and catheters were replaced a few times without resolution.The grounding pad was replaced without resolution.The biosense webster, inc.Representative noted that they were on the phone with the biosense webster, inc.Field representative while troubleshooting the issue.The procedure was canceled as the issue could not be resolved.After the procedure had been canceled, the biosense webster, inc.Representative performed a preventative maintenance on the carto® 3 system (with the biosense webster, inc.Field representative still on the phone) and confirmed that the carto® 3 system was operating per specifications.No harm/complication occurred other than cancelled procedure.Patient outcome was reported as fully recovered (no residual effects).However, the patient required prolonged hospitalization because the procedure was cancelled.Reported issue was investigated by the device manufacturer.It was found that the customer did not perform step 1 of troubleshooting error 7, according to instructions for use (ifu):¿ 1.Immediately disconnect body surface ecg cable and all catheter extension cables from the patient interface unit (piu)¿.As result, the power reject failed to clean the noise.The biosense webster, inc.Field representative contacted biosense webster, inc.Representative and confirmed that the account completed multiple cases without an issue since.Error 7 issue was not duplicated.The system is operational.The history of customer complaints reported during the last year associated with carto 3 system # 13374 was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the system # 13374, and no internal actions related to the reported complaint condition were identified.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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