BOSTON SCIENTIFIC CORPORATION 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 12/15/2020 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The 85% stenosed, target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.00mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation at nominal pressure, the balloon ruptured due to severe calcification.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was good.
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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 contrast in the inflation lumen, and blood and contrast in the balloon.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The outer shaft was stretched down for 4mm starting 2mm distal of the exit notch prevented the balloon from inflating.There was a pinhole at the distal marker band.There was no marker band damage detected.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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It was reported that balloon rupture occurred.The 85% stenosed, target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.00mm x 15mm maverick balloon catheter was advanced for dilatation.However, duirng inflation at nominal pressure, the balloon ruptured due to severe calcification.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was good.
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Search Alerts/Recalls
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