The product investigation was completed.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and electrical evaluation of the returned device were performed following bwi procedures.Visual analysis revealed a hole in the pebax area with no foreign material inside.Also the dome was squashed and electrode #2 was observed lifted.An electrical test was performed, and an open circuit was found in the tip area.The damage observed could be related to the reported event.The root cause of the damage in the pebax and electrodes could be related to the handling during procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device [31096414m] number, and no internal actions related to the reported complaint condition were identified. the electrical issue reported by the customer was confirmed.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 reference number: (b)(4).
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