Model Number 7590 |
Device Problems
Break (1069); Difficult to Advance (2920); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/20/2020 |
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 on a 5x400mm, concentric, in-stent re-stenosed lesion in the left femoral artery.There was some resistance during advancement of the 4.00mm x 20mm maverick balloon and the shaft broke outside of the patient.The procedure was successfully completed with a different device without issue or patient injury.
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Manufacturer Narrative
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Returned product consisted of a maverick 2 balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The hypotube was separated 8cm from the hub.The hypotube was twisted.Microscopic examination revealed damage to the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that could have contributed to the difficulty to advance.
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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 on a 5x400mm, concentric, in-stent re-stenosed lesion in the left femoral artery.There was some resistance during advancement of the 4.00mm x 20mm maverick balloon and the shaft broke outside of the patient.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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