Model Number 7164 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/02/2021 |
Event Type
malfunction
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Event Description
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It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed.A 2.50mm x 20mm emerge balloon catheter was selected for used.However, during procedure the shaft was broken.The procedure was completed with another of same device.Further information has been requested but has not been provided at this time.
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Event Description
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It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed.A 2.50mm x 20mm emerge balloon catheter was selected for used.However, during procedure the shaft was broken.The procedure was completed with another of same device.Further information has been requested but has not been provided at this time.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There was blood in the hub upon device return.At 62cm from the strain relief the hypotube was separated.The separated ends were ovaled in shape indicating the device was kinked prior to separation.At 55.6cm distal from the separation, the shaft was kinked.There was contrast and blood present in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded and had contrast present in the balloon.
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Search Alerts/Recalls
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