BOSTON SCIENTIFIC CORPORATION AGENT; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 3825 |
Device Problems
Difficult to Advance (2920); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2021 |
Event Type
malfunction
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Event Description
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It was reported that a balloon expanded irregularly.The 50% stenosed target lesion was located in the left anterior descending artery (lad).Following predilitation, a 3.50mm x 20.00mm agent drug coated balloon (dcb) was advanced to the target lesion, but the balloon size expanded irregularly while inflating the device.It was noted that a half segment was larger than the designated balloon size versus the compliance chart.It was noted that the cause of the event was likely due to difficulty advancing the balloon catheter to the in stent restenosed lesion.While removing the agent balloon, it was noted that the catheter balloon wrapping (50% distal segment of the balloon wrapping) was noticed to have been loose.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.
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Event Description
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It was reported that a balloon expanded irregularly.The 50% stenosed target lesion was located in the left anterior descending artery (lad).Following predilitation, a 3.50mm x 20.00mm agent drug coated balloon (dcb) was advanced to the target lesion, but the balloon size expanded irregularly while inflating the device.It was noted that a half segment was larger than the designated balloon size versus the compliance chart.It was noted that the cause of the event was likely due to difficulty advancing the balloon catheter to the in stent restenosed lesion.While removing the agent balloon, it was noted that the catheter balloon wrapping (50% distal segment of the balloon wrapping) was noticed to have been loose.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.It was later reported that the manufacturer of the stent device related to the in stent restenosis is unknown.
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Manufacturer Narrative
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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 contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.Inflated balloon did not appear deformed.Marker bands were 20mm from proximal to distal end.Diameter of balloon measured at 3.5mm at proximal marker band, middle of balloon, and distal marker band.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported deformed balloon.
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Search Alerts/Recalls
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