Model Number M004CRBS3050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hematoma (1884)
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Event Date 11/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
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Event Description
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Clinical study(b)(4).It was reported that following a cryoablation procedure with a polarsheath, the patient experienced a hematoma at the puncture site to the knee.The patient was given oral analgesic and support stockings.The outcome of the event was ongoing.The suspected cause was reported as "af ablation." the device is not expected to be returned for analysis.
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Event Description
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Clinical study: (b)(4).It was reported that following a cryoablation procedure with a polarsheath, the patient experienced a hematoma at the puncture site to knee.The patient was given oral analgesic and support stockings.The outcome of the event is ongoing.The suspected cause was reported as "af ablation." the device is not expected to be returned for analysis.It was further reported that the event resolved on (b)(6) 2020.
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Manufacturer Narrative
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This supplemental report is being submitted to report event resolution date.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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