Model Number M004CRBS3050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Atrial Fibrillation (1729); Fever (1858); Hemoptysis (1887); Pneumonia (2011)
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Event Date 11/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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Weight: (b)(6).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)(6).It was reported that day following a cryoablation procedure with a polarx balloon catheter and polarsheath, the patient felt unwell, went to the local emergency department and was hospitalized.An electrocardiogram (ecg) showed atrial fibrillation (af).He was noted to also have hemoptysis and a fever.The patient was given amiodarone and went back into sinus rhythm (sr) the next day.Two days later, the patient went back into af but reverted back to sr on the same day.A diagnosis of right sided community acquired pneumonia and infection driven atrial fibrillation recurrence was made.The patient was discharged two days later.The event outcome was reported as ongoing.The devices are not expected to be returned for analysis.
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Event Description
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Clinical study polar ice py003 it was reported that day following a cryoablation procedure with a polarx balloon catheter and polarsheath, the patient felt unwell, went to the local emergency department and was hospitalized.An electrocardiogram (ecg) showed atrial fibrillation (af).He was noted to also have hemoptysis and a fever.The patient was given amiodarone and went back into sinus rhythm (sr) the next day.Two days later, the patient went back into af but reverted back to sr on the same day.A diagnosis of right sided community acquired pneumonia and infection driven atrial fibrillation recurrence was made.The patient was discharged two days later.The event outcome was reported as ongoing.The devices are not expected to be returned for analysis.It was further reported that the event resolved.
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Manufacturer Narrative
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A.4.Weight: 88.5 kg.It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.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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