| Catalog Number SMART TOUCH UNIDIRECTNAL |
| Device Problem
Patient Device Interaction Problem (4001)
|
| Patient Problem
Cardiac Tamponade (2226)
|
| Event Date 11/18/2021 |
|
Event Type
Injury
|
|
Event Description
|
|
It was reported that a patient underwent an atrial fibrillation (afib) ablation with an unknown smart touch unidirectional sf catheter and suffered cardiac tamponade which required pericardiocentesis and prolonged hospitalization.It was also reported that during the procedure the application got ¿stuck in, he couldn¿t use the geometry and all the options have been stuck¿.Also, other option new map has been impossible to do.Managed to complete the case without the application just only with the study.There was a 10-minute delay.Additional information was received on 14-dec-2021.It was reported that the adverse event occurred after biosense webster inc.Product use.The physician¿s opinion regarding the cause of this adverse event is that this is procedure and patient condition related.Intervention provided was a pericardial effusion and a drain was provided.The patient was placed under observation and so extended hospitalization was required.The patient fully recovered.A smartablate generator was used in the case.There were no issue/error/failure related to smartablate generator kit-ww and smartablate pump kit-ww.A transseptal puncture was performed with a st jude medical, sl0, transseptal needle brk.There was no evidence of a steam pop.Flow settings were 2ml/min, 8ml/min, 15ml/min according to recommended settings for the catheter.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.No error messages were observed on biosense webster equipment during the procedure; however, at the end of the procedure, the study was stuck in a ripple propagation mode, even after the propagation window closed.Force visualization used was visitag module and the parameters for stability were: 2.5mm, time: 3sec, fot: 25 % of 3g, tag size: 3mm with no additional filter used with the visitag.Ablation index was used prospectively as the color option.Since the event (cardiac tamponade) is life threatening and required intervention to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.
|
| |
|
Manufacturer Narrative
|
|
Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
|
| |
|
Manufacturer Narrative
|
|
Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
|
| |
|
Event Description
|
|
It was reported that a patient underwent an atrial fibrillation (afib) ablation with an unknown smart touch unidirectional sf catheter and suffered cardiac tamponade which required pericardiocentesis and prolonged hospitalization.It was also reported that during the procedure the application got ¿stuck in, he couldn¿t use the geometry and all the options have been stuck¿.Also, other option new map has been impossible to do.Managed to complete the case without the application just only with the study.There was a 10-minute delay.Additional information was received on (b)(6) 2021.It was reported that the adverse event occurred after biosense webster inc.Product use.The physician¿s opinion regarding the cause of this adverse event is that this is procedure and patient condition related.Intervention provided was a pericardial effusion and a drain was provided.The patient was placed under observation and so extended hospitalization was required.The patient fully recovered.A smartablate generator was used in the case.There were no issue/error/failure related to smartablate generator kit-ww and smartablate pump kit-ww.A transseptal puncture was performed with a st jude medical, sl0, transseptal needle brk.There was no evidence of a steam pop.Flow settings were 2ml/min, 8ml/min, 15ml/min according to recommended settings for the catheter.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.No error messages were observed on biosense webster equipment during the procedure; however, at the end of the procedure, the study was stuck in a ripple propagation mode, even after the propagation window closed.Force visualization used was visitag module and the parameters for stability were: 2.5mm, time: 3sec, fot: 25 % of 3g, tag size: 3mm with no additional filter used with the visitag.Ablation index was used prospectively as the color option.Since the event (cardiac tamponade) is life threatening and required intervention to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.
|
| |
|
Search Alerts/Recalls
|
|
