Model Number 7585 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/03/2020 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 1.50mm x 15mm maverick 2 balloon catheter was advanced for dilatation.However, upon withdrawal, the delivery shaft was fractured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
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Event Description
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It was reported that shaft break occurred.The 80% stenosed target lesion was located in a mildly tortuous and severely calcified left anterior descending artery.A 1.50mm x 15mm maverick 2 balloon catheter was selected for use; however, upon withdrawal, the delivery shaft was fractured.The device was completely removed by simply pulling it out.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
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Manufacturer Narrative
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Device evaluation 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 2.5cm 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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Search Alerts/Recalls
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