Model Number D134805 |
Device Problems
Failure to Sense (1559); Patient Device Interaction Problem (4001)
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Patient Problem
Paralysis (1997)
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Event Date 06/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter phone: (b)(6).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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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) procedure with two thermocool® smart touch® sf bi-directional navigation catheter and suffered a diaphragmatic paralysis.When the smart touch catheter was connected error 105 (magnetic sensor error) displayed.The cable was changed but the issue continued.The catheter was changed, and the issue resolved.During ablation of the superior vena cava there was difficulty moving the diaphragm.The diaphragm gradually recovered on its own.The procedure completed without any action and the patient left from the room as usual.The diaphragmatic paralysis was considered non-serious, moderate/minimal.No further information is available at this time.The magnetic sensor error is not mdr-reportable.However, since this event is life threatening and required interventions to prevent permanent impairment of a body function or permanent damage to a body structure, then is to be considered serious and mdr-reportable.This report is for the 1st of 2 thermocool® smart touch® sf bi-directional navigation catheters.The other catheter was reported in manufacturer report number 2029046-2021-01054.
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Manufacturer Narrative
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On 7-jul-2021, bwi received additional information regarding the event.This adverse event was discovered during use of biosense webster products.No intervention was provided.Patient outcome was reported as improved.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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Manufacturer Narrative
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On 26-jul-2021, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not 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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Manufacturer Narrative
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On 16-aug-2021, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation (afib) procedure with two thermocool® smart touch® sf bi-directional navigation catheter and suffered a diaphragmatic paralysis.When the smart touch catheter was connected error 105 (magnetic sensor error) displayed.The cable was changed but the issue continued.The catheter was changed, and the issue resolved.Device evaluation details: visual analysis of the returned product revealed that no damage or anomalies were observed on the smart touch sf (bidirectional) catheter.The device was visually inspected and it and it was found in good conditions.The electrical and temperature features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.Then, magnetic sensor functionality was tested on carto and error 105 was observed.A failure analysis was performed, the catheter was dissected and the sensor values were found within specifications, with this information, the failure can be attributed to a potential pc board failure.A manufacturing record evaluation was performed for the finished device 30509644m number, and no internal action was found during the review.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The instructions for use contain the following warning stated in the carto 3 system manual: the magnetic sensor of the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.The magnetic error was confirmed, however, the root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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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