Age at time of event: 18 years or older.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, 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 removal difficulties occurred.Vascular access was obtained via the left side.The chronic totally occluded (cto) lesion was located in the highly calcified right superficial femoral artery (sfa).The iliac was also noted to be highly calcified.A chariot guiding sheath was selected.The physician was unable to get through the cto after about 45 minutes.While removing the sheath, the sheath broke near the top and remained inside the patient.The physician accessed the right side, placed a sheath, pushed the sheath up a bit.The surgeon then made a small incision and was able to fish out the remaining portion of the chariot guiding sheath.No patient complications were reported and the patient's status is fine.
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