It was reported that a patient underwent an endometrial thermal ablation procedure on (b)(6) 2015.During the procedure, it was noted that the balloon had a perforation and leaked and therefore, would not get to the required pressure.Another like device was used to complete the procedure with no adverse patient consequences.
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(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.(b)(4).
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