It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smart touch® sf uni-directional navigation catheter (stsf) for which biosense webster¿s product analysis lab (pal) identified a reddish material inside the pebax and a hole leaving internal parts exposed.Initially, it was reported that after starting ablation, the force readings were spiking on the graph.The stsf catheter cable was replaced without resolution.The catheter was replaced, and the issue resolved.No adverse patient consequence was reported.The force issue was assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 06-feb-2024, there was a reddish material inside the pebax and a hole leaving internal parts exposed.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 06-feb-2024.
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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 that there was reddish material inside the pebax and a hole leaving internal parts exposed.Then, a screening test was performed, and the device was recognized and visualized correctly; however, negative force vector appeared in the system with high force readings due to the damaged and reddish material on the pebax.A manufacturing record evaluation was performed for the finished device 31180234l number, and no internal actions related to the reported complaint condition were identified.The force 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: in order to achieve optimal force reading accuracy and stability, allow the catheter to warm up for 2 minutes after connection to the carto¿ 3 system, prior to use of the force feedback feature.Zero the contact force reading when moving the catheter from one chamber of the heart to another or upon reinsertion.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
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