One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.Blood was visible on catheter body and windings.As received, the catheter tip and distal lead wire were completely broken off and the balloon was found to be torn around the balloon circumference near the proximal windings.The broken section and torn balloon were not returned.Furthermore, the proximal windings and proximal electrode were slid to distal side.Closer examination confirmed that the tip of the broken section was tapered and cross surface of the broken catheter tip appeared to be uneven and rough.Residual latex was observed under the proximal windings.No visible damage to the proximal windings or returned syringe was observed.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of balloon issue 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.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.It is common clinical practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry or leakage condition before use of the catheter.It is unknown if user or procedural factors may have contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
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