It was reported that the patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and post procedure the bwi product analysis lab identified a broken pebax with internal parts exposed.During the procedure, the force value could not be zeroed.A second device was used to complete the operation.There was no adverse event reported on patient.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
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The product investigation was completed.Device evaluation details: the device was returned to biosense webster for evaluation.Bwi conducted a visual inspection and a screening test.Visual inspection was performed and the pebax component at the tip was observed broken with internal parts exposed.Then, the device was connected to the carto 3 and error 105 and 106 were observed due to an open circuit in the tip area.A manufacturing record evaluation was performed for the finished device number 31041420l, and no internal action was found during the review.The force issue reported by the customer was confirmed based on the open circuit inside the tip.The potential cause of the broken condition could be related to the handling of the device after procedure however, this cannot be conclusively determined.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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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