A product evaluation was completed.The reported event of pacing issue was confirmed.Continuity testing found that a short condition occurred between the proximal and distal circuits in the y adaptor.No open or short condition was observed in the leadwires between distal side of y adaptor and the electrodes.No visible damage was observed from catheter body, balloon, and windings.The balloon inflated clear and concentric and remained inflated for 5min.Without leakage.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A product risk assessment was previously generated to cover the short condition at the y adaptor between proximal and distal lead wires for the bipolar pacing catheters for products nonconformance with moderate, major, or critical severity.The root cause is potentially related to manufacturing.A device history record review was completed and documented that device met all specifications upon distribution.Corrections to the h6 codes type of investigations, investigation findings, and investigation conclusions were made.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 a part of the monthly review.
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