It was reported that a swan ganz catheter was unable to pace during use.The issue was resolved by replacing the catheter.The background of malfunction occurrence, the phase when the catheter got unable to pace, what kind of surgery and examination the catheter was used for or whether the patient had cardiac conduction defect are unknown.Patient demographic information was requested but unavailable.There were no patient complications reported.
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A product evaluation was completed.The reported event of pacing issue was confirmed.Continuity testing confirmed a full open condition in the distal circuit.The proximal circuit was found to be continuous.A cut down of the catheter body was performed just proximal of the proximal electrode to expose the pacing lead wires.The distal lead wire was found to be broken, detached around the solder joint.It was confirmed that the distal circuit was continuous from broken lead wire to distal connector pin.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 min.Without leakage.No visible damage or defect was observed from the balloon, windings returned syringe and catheter body.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 full open and intermittent condition at tip for bipolar pacing catheters for products nonconformance with moderate, major, or critical severity.Additionally, a capa was generated to address the pacing difficulty failure effect for bipolar products with full open, intermittent, and short conditions.The root cause was related to manufacturing.A device history record review was completed and documented that device met all specifications upon distribution.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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