(b)(4).Visual inspection was performed on the returned device.The separation was confirmed.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty to remove, shaft separation, removal of foreign body and additional treatment appears to be due to operation context of the procedure.It should be noted that the trek rx and mini trek rx, global instructions for use states: the trek rx coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion and balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.(b)(4).
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