One bipolar pacing catheter with attached monoject 1.3cc limited volume syringe was returned for evaluation.As received, the syringe plunger was tied by attached string.The catheter was stained yellow between the 30 cm marker and the 40 cm marker.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.No visible damage to the catheter body, balloon, windings or returned syringe was observed.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 ¿it became unable to pace after the catheter was secured during use¿ was not confirmed.There was no indication of a manufacturing nonconformance noted during the analysis.It is not known if some clinical or procedural factors may have contributed to the event.No actions will be taken at this time.
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