Model Number 85056 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Swelling/ Edema (4577)
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Event Date 07/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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During an ablation procedure to treat supraventricular tachycardia a blazer ii htd catheter was selected for use.It was reported that the temperature did not meet the ablation requirements of the lesion.Repeated ablation attempts resulted in edema on the contact surface of the lesion."emergency treatment" might have been performed to treat the edema, however the details are unknown.The procedure was cancelled and rescheduled.No additional complications were reported and the patient's current condition is fine.
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Manufacturer Narrative
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The device was received by boston scientific for analysis.Upon product analysis it was observed that the continuity test was performed, and the device was found within specifications.No opens or shorts were found.The ablation was verified by using the maestro generator 4000, and the device was found within specifications.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
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Event Description
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During an ablation procedure to treat supraventricular tachycardia a blazer ii htd catheter was selected for use.It was reported that the temperature did not meet the ablation requirements of the lesion.Repeated ablation attempts resulted in edema on the contact surface of the lesion."emergency treatment" might have been performed to treat the edema, however the details are unknown.The procedure was cancelled and rescheduled.No additional complications were reported and the patient's current condition is fine.
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Search Alerts/Recalls
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