(b)(4).The caravel microcatheter was returned for evaluation.The reported detachment of the tip was confirmed.The torn end of the tip was crushed into an oval shape and the stretched inner jacket and the distal end of the braid tube were exposed.Proximal to the torn end of the tip, circumferential cracks were observed.These findings indicated that tensile stress had contributed to separation of the tip.Measurement of the remaining tip suggested that the tip was torn off at the junction of polymer-only and polymer-and-braid tube segments located at approximately 2mm from the distal end of the tip.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Based on the obtained information and investigation outcome, it was presumed that tensile stress had most likely contributed to the observed separation of the tip.The applied tensile stress would exceed the product design limit when the tip was being trapped by the concomitant balloon during removal.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [warnings] if any resistance or something abnormal is felt when operating this microcatheter, do not continue the manipulation while the causes are unclear.If it is suspected that this microcatheter is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications.(continuing the manipulation while the cause of the problem is not identified may cause damage to this microcatheter, and damage the blood vessel.); and, [malfunction and adverse effects] separation.
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It was reported that the tip of an asahi caravel microcatheter detached during a thrombectomy of the distal lcx.The microcatheter was used to support a guide wire that was delivered to the lesion.When the guide wire successfully reached the lesion, a non-asahi kusabi exchange balloon catheter was used to replace the microcatheter.Upon removal, the tip of the microcatheter became trapped by the balloon and torn apart.A thrombectomy catheter was then delivered to suction blood clots as well as the detached tip.Retrieval of the detached tip was unsuccessful.As the detached tip was located far distal in the vessel and would not affect hemodynamics, the physician decided to leave it in situ.The patient was fine after the procedure without adverse effect associated with the detached tip.
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