Device investigation details: a picture of the complaint device was provided by the customer to aid in the investigation.The picture received was evaluated following biosense webster's procedures.According to pictures provided by the customer, it looks like the pouch of the catheter was cut off with a sharp object, however, this cannot be conclusively determined.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.Note: (b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (b)(4).
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