BOSTON SCIENTIFIC SCIMED, INC MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7585 |
Device Problem
Material Rupture (1546)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2020 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The 93% stenosed, 2mmx15mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.00mm x 15mm maverick 2 balloon catheter was advanced for dilation.However, during inflation at 1116 kilopascal, the balloon burst.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient's status was stable.
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Event Description
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It was reported that balloon rupture occurred.The 93% stenosed, 2mmx15mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.00mm x 15mm maverick 2 balloon catheter was advanced for dilation.However, during inflation at 1116 kilopascal, the balloon burst.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: the 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 contrast and blood in the inflation lumen, and blood in the guidewire lumen.The balloon was loosely folded.There was a circumferential tear at the proximal end of the balloon.The balloon was prolapsed and had been pulled over the tip of the device.There was a hole in the outer shaft 52mm from the exit notch.The core wire was protruding from the hole.Inspection of the remainder of the device presented no other damage or irregularities.
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