BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7163 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.
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Event Description
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It was reported that the balloon was an incorrect length.The 75% stenosed, straight vessel target lesion was located in the right coronary artery (rca).A 2.50mm x 15mm emerge balloon catheter was advanced to dilate the target lesion.During inflation, the balloon shoulder on the proximal side of the marker band was longer.It was noted to be 1.5 times longer than the proximal marker band.On the distal side, the balloon inflated as expected where the balloon shoulder was at the outer edge of the distal maker band.The procedure was completed successfully with the emerge balloon catheter.No patient complications resulted and the patient was reported to be stable following the procedure.
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Manufacturer Narrative
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Age at time of event: 18 years or older.Device evaluated by mfr: the returned product consisted of an emerge 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 defects detected.The balloon length measured 15mm.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported balloon length issue.
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Event Description
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It was reported that the balloon was an incorrect length.The 75% stenosed, straight vessel target lesion was located in the right coronary artery (rca).A 2.50mm x 15mm emerge balloon catheter was advanced to dilate the target lesion.During inflation, the balloon shoulder on the proximal side of the marker band was longer.It was noted to be 1.5 times longer than the proximal marker band.On the distal side, the balloon inflated as expected where the balloon shoulder was at the outer edge of the distal maker band.The procedure was completed successfully with the emerge balloon catheter.No patient complications resulted and the patient was reported to be stable following the procedure.
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