BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7015 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/19/2018 |
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 outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a kink to the hypotube 60.5cm from the hub.The hypotube is separated 63.3cm from the hub and appeared to have been kinked prior to separation.Microscopic examination revealed no additional damages.There is blood present in the guide wire lumen and the balloon is still tightly folded.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 21-dec-2018.It was reported that shaft kink occurred.During introduction of a 4.0mm x 15mm quantum maverick balloon catheter, it was noted that the delivery shaft of the balloon 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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