The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed a cut on pebax with reddish-brown material inside and internal parts exposed; however, the cut could be related to the handling since in the process there are control inspection points to avoid this kind of issue; however, this could not be conclusively determined.The magnetic and force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.The blood found inside the pebax area may contribute to the force issue.A manufacturing record evaluation was performed for the finished device 31047143l 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.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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It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and post-procedure the bwi product analysis lab identified a cut on the pebax with internal parts exposed.During the procedure, a high force error was identified as ablation occurred.The catheter was replaced, the issue was resolved, and the procedure was continued.No patient consequences were reported.
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