| Model Number D134805 |
| Device Problem
Patient Device Interaction Problem (4001)
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| Patient Problem
Cardiac Tamponade (2226)
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| Event Date 11/16/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Initial reporter phone: (b)(6).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 female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.No product defect reported.A steam pop occurred.The physician commented that the popped ablation was 16 down with visitag information, 40 w 23 sec cf 10 g average and 116 ohm start.Since blood pressure decreased 30 seconds after ablation, 600 cc of drainage was conducted, and hemostasis was achieved.We received a comment that this event was not related to the product.Steam pop is not mdr-reportable.The adverse event occurred on (b)(6) 2021.This adverse event was discovered during use of biosense webster products.The physician commented that the event was not related to bwi product.Medical intervention provided: drainage was performed, and 600 cc of blood was aspirated.It was not reported extended hospitalization was required.Prior to noting the pe or ct ablation was performed.The event occurred during ablation phase.During ablation, steam pop occurred, 30 seconds after the ablation, blood pressure decreased, and pericardial effusion was confirmed.Correct catheter settings were selected on the generator.The ablation was conducted at 40w/23seconds, contact force average 10mg, impedance 116o at start time, and completed with 16o down when steam pop occurred.It was not reported that inappropriate use was conducted without ifu.It was not reported that there was any error message observed.Force visualization feature used: visitag.The visitag module was used.It was not reported additional filters were used with visitag.Since the event is life threatening and required cancellation of the procedure 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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Manufacturer Narrative
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Initial reporter phone: (b)(6).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 female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.No product defect reported.A steam pop occurred.The physician commented that the popped ablation was 16 down with visitag information, 40 w 23 sec cf 10 g average and 116 ohm start.Since blood pressure decreased 30 seconds after ablation, 600 cc of drainage was conducted, and hemostasis was achieved.We received a comment that this event was not related to the product.Steam pop is not mdr-reportable.The adverse event occurred on (b)(6) 2021.This adverse event was discovered during use of biosense webster products.The physician commented that the event was not related to bwi product.Medical intervention provided: drainage was performed, and 600 cc of blood was aspirated.It was not reported extended hospitalization was required.Prior to noting the pe or ct ablation was performed.The event occurred during ablation phase.During ablation, steam pop occurred, 30 seconds after the ablation, blood pressure decreased, and pericardial effusion was confirmed.Correct catheter settings were selected on the generator.The ablation was conducted at 40w/23seconds, contact force average 10mg, impedance 116o at start time, and completed with 16o down when steam pop occurred.It was not reported that inappropriate use was conducted without ifu.It was not reported that there was any error message observed.Force visualization feature used: visitag.The visitag module was used.It was not reported additional filters were used with visitag.Since the event is life threatening and required cancellation of the procedure 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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Manufacturer Narrative
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On 9-feb-2022, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30629152l and no internal action related to the complaint was found during the review.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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Search Alerts/Recalls
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