Model Number 3825 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/25/2019 |
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 occurred.A percutaneous coronary intervention was being performed.Vascular access was obtained via the right radial artery.The target lesion was located in the non tortuous and non calcified, eccentric, de novo lesion in the left circumflex coronary artery.A 2.75 mm x 15.00mm agent drug-coated balloon was advanced into the guide catheter where the balloon shaft broke.The procedure was successfully completed with a different device without issue or patient injury.
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Manufacturer Narrative
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Device is a combination product.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the hypotube was separated 54.8cm from the hub.There were multiple kinks along the hypotube.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the hypotube was separated but appeared to have been kinked prior to separation.
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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.Vascular access was obtained via the right radial artery.The target lesion was located in the non tortuous and non calcified, eccentric, de novo lesion in the left circumflex coronary artery.A 2.75 mm x 15.00mm agent drug-coated balloon was advanced into the guide catheter where the balloon shaft broke.The procedure was successfully completed with a different device without issue or patient injury.
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Search Alerts/Recalls
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