Note: g01 "biological and chemical" is the preferred component code but is not available for fda submission.On (b)(6)2020, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an unspecified cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where blood clot occurred.When the catheter was pulled out, something like a blood clot was attached to the tip.The clot was observed at the final stage of the procedure (about 2 hours after the start of ablation).The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.Device evaluation details: visual inspection was performed and the device was visually inspected and it was found a clot at the tip.Per the event, the catheter was tested for electrical performance and stockert compatibility and it was found within specifications.Then, a cool flow pump test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.A manufacturing record evaluation was performed for the finished device 30410086m number, and no internal actions related to the reported complaint condition were identified.The customer complaint has been confirmed.The customer complaint regarding the clot on the tip has been verified.Additionally, clot is a physical phenomenon of rf; it can be the normal result of the ablation process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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