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Model Number 39540 |
Device Problems
Material Perforation (2205); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that a catheter perforation occurred.A 260cm zipwire and 035 inches x 135cm rubicon were selected for use.During the procedure, the physician was trying to cross a very calcified aortic bifurcation using 035 inches x 135cm rubicon and a zipwire 260cm.The rubicon was kinked and upon removing the catheter it was slightly bent.Additionally, when the tech flush the rubicon it was noted that there were holes in the side of the catheter and when the zipwire was removed the coating on the tip of the wire had sheared off.The physician continued with the case and was able to cross the aortic bifurcation and successfully performed atherectomy using a 2.5 rotablator on the lesions.Furthermore, it was noted after a post treatment angiogram that there was something in the mid superficial femoral artery (sfa).It was presumed to be the coating tip of the zipwire, so the physician deployed a 6mm x 40mm eluvia stent to ensure the object did not travel and possibly embolize the distal artery.The post angiogram pictures confirmed brisk flow throughout the rle.The device was simply removed, and the procedure was completed with a non-boston scientific device.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.The device was visually and microscopically inspected for damage.The devices shaft showed damage in the form of multiple bends/kinks located 122cm from the hub to the tip.There was a hole in the catheter shaft located 124.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
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Event Description
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It was reported that a device fracture occurred.A 260cm and 035 x 135cm rubicon zipwire were selected for use.During the procedure, the physician was trying to cross a very calcified aortic bifurcation using an 035 x 135cm rubicon and a zipwire 260cm.The rubicon was kinked and upon removing the catheter it was slightly bent.Additionally, when the tech flush the rubicon it was noted that there were holes in the side of the catheter and when the zipwire was removed the coating on the tip of the wire had sheared off.The physician continued with the case and was able to cross the aortic bifurcation and successfully performed atherectomy using a 2.5 rotablator on the lesions.Furthermore, it was noted after a post treatment angiogram that there was something in the mid superficial femoral artery (sfa).It was presumed to be the coating tip of the zipwire so the physician deployed a 6mm x 40mm eluvia stent to ensure the object did not travel and possibly embolize the distal artery.The post angiogram pictures confirmed brisk flow throughout the rle.The procedure was completed with a non-bsc device.There were no patient complications reported.
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Search Alerts/Recalls
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