The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.The device was connected to carto 3 system, and the device was visualized and recognized correctly.However, error 106 appeared on the system due to an open circuit in the tip area.A manufacturing record evaluation was performed for the finished device 31168788m number, and no internal actions related to the reported complaint condition were identified.Since reddish material was observed, this failure could be also related to the force issue reported; therefore, the customer complaint was confirmed.It should be noted that product failure is multifactorial.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).
|
It was reported that a patient underwent an atrial fibrillation - paroxysmal ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and post procedure the bwi product analysis lab identified a hole in the pebax.During the procedure, there was a problem with the force of the catheter.A second device was used to complete the operation.There was no adverse event reported on patient.Multiple follow-up attempts were made to obtain additional information.However, no other details or information were provided.
|