BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7164 |
Device Problems
Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The returned product consisted of an emerge balloon catheter.Microscopic and visual examination of the device identified numerous hypotube kinks.There was contrast in the inflation lumen and balloon, and blood within the guidewire lumen, consistent with use.The balloon was loosely folded.There was no damage observed with the hub, which would indicate a possible connection problem.The emerge balloon catheter was successfully connected to an inflation device, filled with water and connected to the inflation port to inflate the device.There was a pinhole noted 6mm distal to the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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Reportable based on device analysis completed on 05feb2021.It was reported that device to device incompatibility occurred during a percutaneous coronary intervention on a patient with coronary artery disease.While attempting to inflate a 3.50mm x 20mm emerge balloon, the balloon disconnected from the luer.The connection was maintained by hand while another balloon (same model) was attached and the procedure was successfully completed.No patient complications were reported in relation to this event.However, device analysis identified a pinhole.
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Search Alerts/Recalls
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