One bipolar pacing catheter with attached monoject 1.3cc limited volume syringe was returned for evaluation.The catheter tip was bent and the angle was found to be approximately 13 degrees, exceeding the specification of <10 degrees.No visible damage to the balloon, windings or returned syringe 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 was not confirmed; however, the report of bent catheter tip was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.
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