One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.No visible damage to the catheter body, balloon, windings or returned syringe was observed.No visible damage to the catheter body, balloon or windings was observed.Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 minutes without leakage.Balloon inflation test was performed using returned syringe with 1.3 cc air by holding the balloon under water.Visual examinations were performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of inability to pace could not be confirmed during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.
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