BOSTON SCIENTIFIC CORPORATION AGENT; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 3825 |
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 12/08/2020 |
Event Type
malfunction
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Event Description
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It was reported that a balloon rupture occurred.The 100% in stent restenosed (isr) target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).Following predilitation, a 3.50 mm x 20.00 mm agent dcb balloon was advanced to dilate the target lesion, but the balloon burst.It was noted that the balloon burst due to the distal hypotube advancing through the calcified isr lesion.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.
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Manufacturer Narrative
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The returned product consisted of an agent (dcb) balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 34.3cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was loosely folded.There was a longitudinal tear 24mm long starting 1mm from the proximal end of the balloon.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.
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Event Description
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It was reported that a balloon rupture occurred.The 100% in stent restenosed (isr) target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).Following predlitation, a 3.50 mm x 20.00 mm agent dcb balloon was advanced to dilate the target lesion, but the balloon burst.It was noted that the balloon burst due to the distal hypotube advancing through the calcified isr lesion.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.
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Search Alerts/Recalls
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