The product investigation was completed.Device evaluation details: a picture showing catheter packaging and device tip was received for analysis, the photo does not provide sufficient information related to the reported event and therefore no result can be obtained from it.Visual analysis of the returned device revealed that the spline b was found bent, the electrode was found lifted, and no residues of pu (polyurethane) on the edge were observed the instructions for use contain the following recommendations: do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.A manufacturing record evaluation was performed for the finished device 30693822l number, and no internal action was found during the review.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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A patient underwent an ablation procedure with a pentaray nav eco for which biosense webster¿s product analysis lab identified that spline b was found bent, the electrode was found lifted, and no residues of pu (polyurethane) on the edge were observed.The finding was identified on (b)(6) 2022.It was initially reported by the customer that during the procedure electrode 11 was physically damaged and the spline c was partially folded.The physician acknowledged that he pushed with intensity during the introduction into the long sheath.No patient consequences were reported.Bent spline is not mdr-reportable.Electrode damage is mdr-reportable.
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