BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7005 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2020 |
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 contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.There was a longitudinal tear 10mm long, starting 1mm proximal of the proximal marker band and extending distally.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 25feb2021.It was reported that shaft kink occurred.The target lesion was located in the left main artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced; however, the delivery shaft was kinked.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed a longitudinal tear on the device.
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