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 09/06/2019 |
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 77.8cm 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.
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Event Description
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Reportable based on device analysis completed on 18oct2019.It was reported that shaft kink occurred.The target lesion was located in the left coronary artery.A 3.5mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, it was noted that the shaft kinked.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient's condition was stable.However, returned device analysis revealed a shaft separation.
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