(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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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It was reported that a catheter difficulty removal, tip detachment and un-retrieved device fragment occurred.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified superior mesenteric artery(sma).An opticross¿ 18 imaging catheter was selected for use.During the procedure, a platinum plus guidewire was crossed into the target lesion with the tip of the guidewire in the distal branch.Under fluoroscopy, the opticross¿ 18 was advanced over the platinum plus guidewire through the stenosis.Upon retraction, the physician felt some resistance and it was noticed, under fluoroscopy, that the distal tip of the opticross¿ 18 was separated from the rest of the catheter but was still mounted on the guidewire.The physician tried to retrieve the detached tip through another catheter but failed.The detached tip then migrated elsewhere in the arterial system and could not be found or retrieved.Another opticross¿ 18 imaging catheter was used to complete the procedure.No patient complications or adverse reactions were noted and patient's status is fine.
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