The device was returned to biosense webster (bwi) for evaluation.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.The magnetic and force feature were tested, and no errors were observed.The force values and the vector were observed within specifications.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 by the customer can be confirmed, as the condition observed in the pebax could have contributed to the failure.Product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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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It was reported that a patient underwent a cardiac ablation procedure with a qdot micro¿ catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.Initially, it was reported that force sensor error was observed.The catheter was replaced with the same type of catheter and the procedure was completed.There is no patient consequence.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 01-dec-2023, there was a hole in the pebax and reddish material inside the pebax was also observed.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 01-dec-2023.
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