The product investigation was completed.Device evaluation details: the catheter was inspected and the following was identified: damaged dome, damaged electrodes, a hole in the pebax, exposed internal parts, and cracked peek housing.Then, magnetic sensor functionality was tested on carto and the catheter failed, error 106 was observed.A failure analysis was performed, and the catheter was dissected on the tip area, loss of electrical continuity at the sensor was found, it was determined that the root cause was an internal failure of the sensor.A manufacturing record evaluation was performed and no internal action was found during the review.The customer complaint was confirmed.The root cause of the electrodes damaged, hole on pebax, internal parts exposed, peek housing cracked and force sensor cable cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc (b)(4).
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It was reported that a patient underwent a atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab identified the following: damaged dome, damaged electrodes, hole in the pebax, exposed internal parts, and damaged peek housing.During the procedure, the physician noticed an unstable pressure value.A second catheter was used to complete the operation.There were no adverse events reported for the patient.The force/pressure value issue noted during the procedure is not reportable.However, the catheter damage is reportable.
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