E1 initial reporter phone: (b)(6) the product investigation was completed.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.Bwi conducted a visual inspection and deflection evaluation of the returned device.Visual analysis of the returned sample revealed a cut on pebax with reddish-brown material inside and internal parts exposed; also, the shaft was bent, however, these conditions could be related to the handling since in the process there are control inspection points to avoid this kind of issue; however, this could not be conclusively determined.Then deflection testing was performed and observed that the tip deflects properly.A manufacturing record evaluation was performed for the finished device 30787529l number, and no internal action was found during the review.The customer complaint was confirmed due bent shaft.However, the reddish brown material (possibly blood) is unrelated to the customer's initial complaint.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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