Model Number D134805 |
Device Problem
Coagulation in Device or Device Ingredient (1096)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.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 a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a blood clot issue occurred.After the procedure was ended, the patient's response was poor and when the patient was examined, it was found that a blood clot had broken off.The timing of the occurrence was not known in detail and it was expected that it occurred during ablation.It is believed that deep sedation and contact force (cf) of the catheter are also factors that might have contributed to the causality of the event.The procedure itself was completed and there was no sequelae.The procedure was completed without patient's consequence.Based on the provided details the patient did not have sequelae, thus this event will not be considered a thromboembolytic event and is assessed as a mdr reportable blood clot ¿malfunction¿ issue without patient consequence.
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Manufacturer Narrative
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Additional information was received on (b)(6) 2020.No error messages were observed on any equipment.There¿s no report of temperature issues.A manufacturing record evaluation was performed for the finished device (b)(6)m number, and no internal actions 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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