BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7010 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 69.6cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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Reportable based on device analysis completed on 20aug2019.It was reported that shaft kink occurred.A 2.0mm x 12mm quantum maverick balloon was advanced for dilatation.However, it was noted that the balloon delivery shaft was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.
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Search Alerts/Recalls
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