It was reported that a patient underwent a cardiac ablation procedure which included a lasso® 2515 nav variable catheter for which biosense webster¿s product analysis lab (pal) identified the device tip to be knotted.Initially, it was reported that a sensor error was observed.No other information was provided, and no adverse patient consequence was reported.The sensor error 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-mar-2024, the device tip was observed knotted.This was assessed as mdr reportable with an awareness date of 06-mar-2024.
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E1.Initial reporter phone: (b)(6) the product was returned to biosense webster (bwi) for evaluation.A visual inspection and a magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis was performed, and the device tip was observed knotted.In addition, corrosion residues were observed on the connector.For the corrosion observed, the printed circuit board (pcb) was measured, and an open circuit was found in the tip area.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The open circuit found during the investigation could be related to the magnetic issue reported by the customer.Therefore, the complaint was confirmed.The potential cause of the tip condition and corrosion could be related to the manipulation of the device after the procedure.However, this cannot be conclusively determined.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.Explanation of codes: investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) / component code: connector/coupler (g04034) were selected as related to the corrosion residue observed.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the knotted tip of the catheter.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the open circuit found on the tip area.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: pc-(b)(4).
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