Model Number 3825 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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It was reported that a shaft break had occurred.A percutaneous coronary intervention was being performed.The 3.00mm x 20.00mm agent drug-coated balloon had apparently snapped while inside the patient and needed to be pulled out.The procedure was successfully completed with a different agent balloon without further issue.
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Manufacturer Narrative
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Device is a combination product.Device returned to manufacturer: the agent balloon was returned and analysis was completed.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the hypotube is separated 45.9cm from the hub.There are multiple kinks along the hypotube.There is blood present in the guidewire lumen and contrast present in the inflation lumen and the balloon is still tightly folded.
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Event Description
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It was reported that a shaft break had occurred.A percutaneous coronary intervention was being performed.The 3.00mm x 20.00mm agent drug-coated balloon had apparently snapped while inside the patient and needed to be pulled out.The procedure was successfully completed with a different agent balloon without further issue.
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Search Alerts/Recalls
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