The product investigation was completed.Device evaluation details: visual analysis revealed that there was a reddish material inside the pebax and a rupture on the surface of the tip area.The magnetic and force feature were tested, and no errors were observed.The force vector was observed within specifications.High force values were observed, this could be related to the reddish material inside the pebax.The root cause of the rupture at the pebax cannot be determined; however, based on the information available, the condition observed most likely was originated in someplace external to the manufacturing environment.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device [31119639l] number, and no internal actions related to the reported complaint condition were identified.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: 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.If the force problem persists, replace the catheter cable or the catheter.In order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.After insertion, slide the insertion tube back toward the handle.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 an atrial fibrillation cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and post procedure the bwi product analysis lab identified a rupture on the tip's surface/pebax.During the procedure, when coming on ablation, the force got exceedingly high before returning to its normal reading when ablation went off.The medical team was able to zero the catheter.The cable was replaced but did not resolve the issue.The catheter was replaced and that resolved the issue.The procedure continued.No patient consequences were reported.
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