(b)(6).(b)(4).According to the complainant, the suspect device was contaminated and has been disposed, therefore it is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that an alair bronchial thermoplasty (bt) catheter was used during a bronchial thermoplasty procedure performed on (b)(6) 2019.On (b)(6) 2019, the patient underwent the second bronchial thermoplasty procedure performed in the superior right lower lobe bronchus (rb6) of the lungs.According to the complainant, during the procedure, when the product was opened and inserted into the patient, the catheter experienced several incomplete activations and the catheter handle icon flashed red on the alair bt controller.The catheter was removed and reportedly, the catheter had two areas of noticeable kinks.They tried to straighten the kinked part but it still did not work.There were no spare catheters so the procedure had to be abandoned.Reportedly, the patient experienced desaturation from the procedure.In the physician's assessment, the patient's condition following the procedure was not directly as a result of the faulty catheter.Reportedly, the patient needed to be intubated and recovered in intensive care unit.The bt procedure was rescheduled for (b)(6) 2019.
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