Our product evaluation lab received one bipolar pacing catheter with attached monoject 1.3 cc volume limited syringe at gate valve and a non-edwards contamination shield which was located on the catheter body between 40 cm and 53.3 cm proximal from catheter tip.The reported issue of catheter damage was confirmed.As received, the catheter tube was completely broken off at approximately 14.8 cm from catheter tip.The cross surfaces of the broken tube appeared blackened, and rough.The broken catheter body sections did not match up.Lead wires were also broken at the broken section.There was a puncture around half of the circumference near the broken section, and the puncture region was also blackened.A kink was found near the broken section also.It was able to open and lock the gate valve without any resistance.An engineering evaluation was performed to assess for any manufacturing related processes which could be correlated to the complaint.As part of the manufacturing process, 100 percent of the units go through an electrical continuity inspection and tip visual inspection.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.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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