It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that in the middle of the procedure, contact sensor default.Only during the ablation firing, the contact indicated "high" even if floating catheter.The contact returned to a "normal" value when the generator was stopped.Problem solved by replacing the catheter.No patient consequence.The customer¿s reported force issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On (b)(6) 2023, the bwi pal revealed that a visual inspection of the returned device found a reddish material inside the pebax and a hole on the surface of the tip area.The findings were reviewed and determined the ¿hole¿ to be mdr reportable malfunction since the integrity of the device has been compromised.
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Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed that there was a reddish material inside the pebax and a hole on the surface of the tip area.The device was connected to carto 3 system, and the device was visualized and recognized correctly; however, error 106 appeared on the system.The hole at the pebax could be related to the issue reported by the customer.The root cause of the hole at the pebax cannot be determined; however, based on the information available, the condition reported 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 batch number, and no internal actions 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 ref.# (b)(4).
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