It was reported that a patient underwent a cardiac ablation procedure with a thermocool® sf nav bi-directional catheter and post-procedure the bwi product analysis lab identified a damage/separation at the tip/shaft transition with exposed components.During the mapping with ablation catheter, the physician took the catheter out of the patient.Under the electrodes, the catheter had damaged.The catheter was replaced and the procedure completed.No patient consequences were reported.
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E1 initial reporter phone: (b)(6).The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed a damage/separation at the tip/shaft transition with exposed components.During the analysis adhesive was observed on the transition area, due this condition, the issue could be related to excessive force during manipulation of the device; however, this cannot be conclusively determined.No damages on the electrodes were observed.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the manufacturing process to avoid this type of damage from leaving the facility.The issue reported by the customer was confirmed due to the damage observed at the tip/shaft transition.The condition matches the information provided by the customer regarding damage under the electrodes.A manufacturing record evaluation was performed for the finished device 31044047l number, and no internal action related to the complaint was found during the review.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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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