Model Number M004CRBSUSC3050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemoptysis (1887); No Code Available (3191); Cough (4457)
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Event Date 01/06/2021 |
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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It was reported that a polarx and polarsheath were used in a procedure on (b)(6) 2020.On 6jan2021 it was reported that the patient has had a continued dry cough since the procedure which as been improving but remains.The patient also has had two episodes of hemoptysis after performing vigorous activity.Per the physician the suspected cause is bronchial injury or lung necrosis.
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Event Description
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It was reported that a polarx and polarsheath were used in a procedure on (b)(6) 2020.On (b)(6) 2021 it was reported that the patient has had a continued dry cough since the procedure which as been improving but remains.The patient also has had two episodes of hemoptysis after performing vigorous activity.Per the physician the suspected cause is bronchial injury or lung necrosis.It was further reported that the ablation procedure was not related to the patient condition.
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Manufacturer Narrative
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The device was not returned for analysis and the complaint as reported could not be confirmed.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
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Search Alerts/Recalls
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