The product investigation was completed.Device evaluation details: the smart touch bidirectional sf device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed a hole and reddish material in the pebax.The device was connected to the carto 3 system and it was recognized; however, error 105 was displayed on the screen due to an open circuit in the tip area.The blood found inside the pebax area may contribute to the magnetic issue.The root cause of the pebax damaged could be related to the procedure however this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 31049481l number, and no internal action was found during the review.The issue reported by the customer 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).
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