BOSTON SCIENTIFIC CORPORATION MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7585 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated 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 62.8cm distal of the strain relief.There was contrast in the inflation lumen, and blood in the guidewire lumen.The balloon was loosely 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 13-aug-2019.It was reported that shaft kink occurred.The 90% stenosed, 16mmx2.0mm target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 2.00mm x 15mm maverick balloon catheter was advanced for dilation.However, it was noted that the delivery shaft of the balloon was kinked 65 cm away from the physician's hands.The procedure was completed with another of the same device.No patient complications nor injuries reported and the patient's status was stable.However, returned device analysis revealed hypotube separation.
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