The product investigation was completed.Device evaluation details: upon receipt, the catheter was visually inspected and it was found a hole at the pebax and reddish material inside it.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor feature was tested and it was working properly, the force values were observed within specifications.The force issue could be related to the hole in the pebax with reddish material inside.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint regarding force issue was unable to duplicate during the product investigation however, the foreign material found inside the pebax area could be related to the reported issue.The root cause of the damage on pebax 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: (b)(4).
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A patient underwent an unspecified ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole in the pebax with reddish material inside it.During the procedure, a current leakage error error was identified and there was noise across all catheter signals (including the thermocool smarttouch and lasso nav).Whenever the ablation catheter was moved, the noise dramatically increased.The rhythm was able to be monitored by the monitor.The ablation catheter was inside the patient body.This was resolved with a change in catheter after troubleshooting.However, the current leakage error recurred with the new catheter during ablation.The catheter was replaced and the procedure continued.No patient consequences were reported.The current leakage is not mdr-reportable.The noise issue is not mdr-reportable.The hole in the pebax is mdr-reportable.
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