The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual inspection of the device revealed no anomalies.The guide wire lumen was observed to be blocked by a clear substance which was most likely crystallized contrast solution.During functional testing, a test guidewire was introduced into the catheter hub and it could not be advanced due to the balloon catheter hub blockage.All attempts to flush the catheter was not successful.A cut was made cut near the distal end and the balloon was inflated.A leak was noted near the distal bond during inflation testing originating from a hole near the distal bond.Based on the information available and analysis of the device, it is possible that continuous flush was not maintained during the procedure due to the crystallized contrast solution observed inside the catheter hub.It is likely that procedural factors contributed to the reported and observed damages limiting the performance of the balloon during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.
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