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 the carto 3 system displayed error 106, force sensor error, after the thermocool® smart touch® sf bi-directional navigation catheter was connected to the patient interface unit (piu).The cable was replaced without resolution.The thermocool® smart touch® sf bi-directional navigation catheter was replaced and the issue resolved.The procedure continued.On 1-nov-2022, the bwi pal revealed that a visual inspection of the returned device found a reddish material inside the pebax and also a hole on the pebax.These findings were reviewed and assessed the issue of a ¿hole¿ in the pebax as an 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 hole in the pebax.Reddish material inside the pebax was also observed.The damage could be related to excessive force or manipulation, but this cannot be conclusively determined.The root cause of the hole remains unknown.Also, the device was connected to carto 3 system and the device was recognized and visualized; however, error 106 appeared.Sensor pad connection in the printed circuit board was measured, and no anomalies were observed.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the reported complaint were identified.The force issue reported can be confirmed due to the condition observed in the pebax.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 ref.# (b)(4).
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