It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and post procedure the bwi product analysis lab identified a hole in the pebax.During the procedure, towards the end of the case, when the medical team would come on ablation the contact force would increase by 20 grams each time.No respiratory movement was detected however the issue persisted.The catheter was replaced, the issue was resolved, and the procedure was continued.No patient consequences were reported.The force issue is not mdr-reportable.Hole in the pebax is mdr-reportable.
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The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed a foreign material inside the tip.The magnetic and force feature were tested.The force values and the vector were observed within specifications.No force issues were observed.The device tip was inspected under microscope after performed the test, and it was found a hole on the surface of the pebax section and a foreign material inside it.It was determined that the damage and the foreign material observed was sustained in someplace external to the manufacturing environment and could be related to the force issue reported by the customer.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 lot number 31041947l, 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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