Visual and functional inspections were performed on the returned device.The reported balloon rupture was unable to be confirmed; however, the noted tear in the inner and outer member at the guide wire exit notch is what likely was perceived as the rupture by the account.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.It was reported that the procedure was to treat a calcified renal artery.It should be noted the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use (ifu) 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, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction, balloon dilatation of a stent after implantation.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.The investigation determined the noted tear in the inner and outer member at the guide wire exit notch appears to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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