It was reported that tip detachment occurred.The patient had very calcified vessels.A 14f isleeve introducer sheath was inserted with no resistance noted.Pre-dilatation was performed with a non-bsc balloon catheter in accordance with the instructions for use (ifu).An acurate neo2 valve was advanced through the 14f isleeve introducer sheath and was successfully implanted.The acurate neo2 delivery system was removed without issue.Post dilatation was performed with a non-bsc balloon catheter in accordance with the ifu.The 14f isleeve was removed from the patient with no resistance noted.After removal of the 14f isleeve introducer sheath from the patient, it was noted on fluoroscopy that a detached fragment of the radiopaque isleeve introducer sheath tip was lodged outside of the vessel.The device fragment was left in the patient.At the time of reporting there were no patient complications, the patient is fine and has been discharged.
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H3: device eval by manufacturer: the 14f isleeve was returned to boston scientific(bsc) and analyzed by a bsc quality engineer.The returned product consisted of a 14f isleeve catheter and photos.Analysis of the photos, isleeve tip, and isleeve sheath included microscopic and visual inspection.The supplied photo showed a small portion of the tip in the anatomy.Analysis revealed the device tip (seam opened) had a small section missing, sheath kinks located 10.5cm, 13.5cm, and 15cm from the tip, sheath damage (abrasions/crazing).2 of the 3 seams were partially opened.Inspection of the rest of the device found no other damage or defect.The reported tip separation was confirmed.
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It was reported that tip detachment occurred.The patient had very calcified vessels.A 14f isleeve introducer sheath was inserted with no resistance noted.Pre-dilatation was performed with a non-bsc balloon catheter in accordance with the instructions for use (ifu).An acurate neo2 valve was advanced through the 14f isleeve introducer sheath and was successfully implanted.The acurate neo2 delivery system was removed without issue.Post dilatation was performed with a non-bsc balloon catheter in accordance with the ifu.The 14f isleeve was removed from the patient with no resistance noted.After removal of the 14f isleeve introducer sheath from the patient, it was noted on fluoroscopy that a detached fragment of the radiopaque isleeve introducer sheath tip was lodged outside of the vessel.The device fragment was left in the patient.At the time of reporting there were no patient complications, the patient is fine and has been discharged.
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