A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified foreign material inside of the pebax.Further inspection indicated that there was a hole on the pebax.The finding was identified on (b)(6) 2022.During the procedure, the hospital reported that no errors were seen--however, the catheter was inappropriately showing clashing icon.Catheter cable was changed but did not fix so catheter was replaced.No patient consequences were reported.Visualization issue is not mdr-reportable.Hole in the pebax is mdr-reportable.
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The bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Device evaluation details: visual analysis of the returned sample revealed foreign material inside the pebax on the smart touch bidirectional sf device.The magnetic sensor functionality test was performed, per bwi procedures.No magnetic sensor issues were observed.During the magnetic sensor functionality test, the device was displayed correctly.However, the foreign material inside the pebax could cause magnetic errors.The device was inspected on the pebax area, under sem microscopy, to identify if there was damage on the pebax, that caused the foreign material inside the pebax.A hole was found in the pebax.It should be noted that device failure is multifactorial.The instructions for use contain the following precautions: flush the catheter with heparinized saline prior to insertion into the body.A manufacturing record evaluation was performed for the finished device number 30625251l, and no internal actions related to the complaint were found during the review.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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