Model Number 7585 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/10/2020 |
Event Type
malfunction
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Event Description
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It was reported that a shaft break occurred.During unpacking of a 2.50mm x 15mm maverick 2 balloon catheter, it was found that the delivery shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 59.4cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.
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Event Description
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It was reported that a shaft break occurred.During unpacking of a 2.50mm x 15mm maverick 2 balloon catheter, it was found that the delivery shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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