The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed. a manufacturing record evaluation was performed for the finished device 30221068m number, and no internal actions related to the complaint was found during the review.Manufacturer's ref.No: (b)(4).
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It was reported that during an ablation procedure before the transseptal was performed the webster catheter formed a knot.Once the knot formed it was very hard to maneuver the device.The knotted catheter was removed by using a larger sheath (st.Jude slo 10f).The procedure was cancelled.The patient remained in observation for 1 additional day.No patient consequence was reported.The biosense webster inc.(bwi) product analysis lab (pal) received pictures for analysis.The photograph investigation was completed on (b)(6)2019.According to the pictures provided by the customer, it was observed that the catheter formed a knot.The customer complaint is confirmed.However, the device has not been returned for analysis.If the device is received in the future, the product analysis will be perform as appropriate in order to find the potential root cause of complaint.A manufacturing record evaluation was performed for the finished device 30221068m number, and no internal actions related to the complaint were found during the review.Information was received on 9/18/2019 that the patient was under local anesthesia.Then on (b)(6)2019 additional information was provided that the patient was treated the next day.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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