It was reported that during a percutaneous transluminal angioplasty, vessel occlusion occurred.The target lesion was located in the left tibialis anterior, distal to the arch of the foot.The physician successfully opened the lesion with pre-dilation with a 2.0x200/150 non-bsc balloon following with the 2.0x150/150 ranger balloon.Post balloon angiogram revealed that the arch was occluded.The procedure was completed with a non-bsc laser ablation system.
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Device is a combination product.Device evaluated by manufacturer - it is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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