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Model Number 35615 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 06/07/2019 |
Event Type
Injury
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Event Description
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It was reported that the device broke and was left inside the patient the target lesion was located in the right common femoral artery (cfa).A.038 accustick ii was selected for use after the physician experienced difficulty in getting intra aterial access.The sheath was successfully placed in the right cfa.During procedure, after a guidewire was placed over the aortic bifurcation and into the left external iliac artery, the physician observed a foreign body present in the left common iliac artery.After examination of the device, it was determined that the foreign body was the radiopaque (ro) marker of the accustick sheath.Snaring was attempted to remove the ro marker but was unsuccessful.Consequently, the physician placed a stent to trap the ro marker preventing embolization.No further patient complications reported and the patient's condition was stable.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.No visual damages were observed with the cannula, dilator, introducer needle and stylet.Residues found in the device indicate use and handling of the device.The radiopaque (ro) marker was detached from the sheath and it was not returned for analysis.Marker impression on the sheath surface indicates the ro marker had been properly assembled and swaged onto the distal end, drag marks toward distal end were observed in the sheath indicating the ro marker was pulled out from the sheath.
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Event Description
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It was reported that the device broke and was left inside the patient the target lesion was located in the right common femoral artery (cfa).A.038 accustick ii was selected for use after the physician experienced difficulty in getting intra aterial access.The sheath was successfully placed in the right cfa.During procedure, after a guidewire was placed over the aortic bifurcation and into the left external iliac artery, the physician observed a foreign body present in the left common iliac artery.After examination of the device, it was determined that the foreign body was the radiopaque (ro) marker of the accustick sheath.Snaring was attempted to remove the ro marker but was unsuccessful.Consequently, the physician placed a stent to trap the ro marker preventing embolization.No further patient complications reported and the patient's condition was stable.
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Search Alerts/Recalls
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