It was reported that a patient underwent an atrial fibrillation - paroxysmal procedure with a thermocool® smart touch¿ electrophysiology catheter and post procedure the bwi product analysis lab identified a hole on the pebax.During the actual procedure, a force issue was identified as well.It was reported that during the operation, the force value could not be zeroed.There was also signal loss on the carto.However, the medical team was able to monitor the patient's heart rhythm through functional anesthesia monitor, defibrillator, etc.During the carto signal loss, the catheter was inside of the patient's body.A second device was used to complete the operation.There was no adverse event reported on patient.Hole in the pebax is mdr-reportable.The force issue is not mdr-reportable.The carto signal loss is also not mdr-reportable.
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The product investigation was completed (both photo analysis and the physical device).Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, no force issues were observed on carto 3 screen.Also, it is not possible to determine if the catheter cannot be zeroed based on the picture provided.Additionally, a signal noise was observed on the carto 3 screen.Visual analysis revealed reddish material and a hole on the surface of the pebax.The magnetic and force feature were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.In addition an electrical test was performed, and no electrical issues were found.Although no force or electrical issues were observed during the test, the damage observed on the pebax could be related to the force and noise issues reported during the procedure; however, this cannot be conclusively determined.The force issue reported by the customer was confirmed.The instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.A manufacturing record evaluation was performed for the finished device number 31008810m, and no internal actions related to the reported complaint were identified.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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