Lot Number 0031699086 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2023 |
Event Type
malfunction
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Event Description
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It was reported via facility medwatch #(b)(4) that catheter entrapment on guidewire and shaft break occurred.A 4.50 x 20mm synergy xd drug eluting stent was advanced for treatment.However, during removal, the balloon got stuck on the wire and could not be removed.It was also noticed that the balloon shaft snapped and broke.The balloon was pulled together with the wire.The procedure was completed with the original device.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by mfr: synergy xd mr us 4.50 x 20mm, catheter was returned for analysis.A visual and tactile examination identified multiple kinking along the length of the hypotube.A visual examination of the distal extrusion identified a break in the midshaft extrusion.The break was located at 22mm proximal from the port site.The extrusion exhibited signs of stretching at the break site as the midshaft was stretched down at the location of the break.Further analysis identified multiple kinking along the hypotube shaft.A microscopic examination of the balloon noted that the balloon exhibited signs of having inflated and was not refolded.The stent had been deployed from the balloon and was not received with the balloon catheter.It was not possible to pass a 0.014 inch size wire through the wire lumen, due the distal extrusion being stretched.
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Event Description
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It was reported via facility medwatch #(b)(4) that catheter entrapment on guidewire and shaft break occurred.A 4.50 x 20mm synergy xd drug eluting stent was advanced for treatment.However, during removal, the balloon got stuck on the wire and could not be removed.It was also noticed that the balloon shaft snapped and broke.The balloon was pulled together with the wire.The procedure was completed with the original device.There were no patient complications reported.
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Search Alerts/Recalls
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