It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax exposing the internal components.Initially it was reported that during an exchange of the catheter, blood was discovered inside the spring mechanism on the tip of the catheter.They replaced the catheter and the procedure continued without further issues.There was no patient consequence reported.Additional information was received.The physician used the deflectable sheath for all his deflections during the procedure and no issue was seen during catheter pullback to exchange for another mapping catheter.Could not see any physical damage.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 06-feb-2024 there was damage in the pebax and traces of blood.Microscopic analysis revealed a hole in the pebax exposing the internal components.This event was originally considered non-reportable, however, bwi became aware of a hole in the pebax exposing the internal components on 06-feb-2024 and have assessed this returned condition as reportable.
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The bwi product analysis lab received the device for evaluation 30-jan-2024.The device evaluation was completed on 06-feb-2024.The device was returned to biosense webster (bwi) for evaluation.The returned device's visual inspection and microscopic analysis were performed following bwi procedures.Visual analysis revealed a damage in the pebax and traces of blood.Microscopic analysis revealed a hole in the pebax exposing the internal components.The root cause of the damage could be related to improper handling, however, this cannot be conclusively determined.The issue reported by the customer was confirmed, a broken pebax was identified during the investigation of the sample received.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.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.Manufacturer's reference number: (b)(4).
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