The bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Device evaluation details: visual analysis of the returned sample revealed reddish material and a hole in the pebax, helix metals are exposed on the smarttouch catheter.The deflection mechanism was tested, and it failed.Further investigation revealed the t bar component was slid down inside the tip causing the improper deflection condition.The evaluation determined that the blood inside the pebax area found could not be related to the reported issue.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device [30377622m] number, and no internal actions related to the reported complaint condition were identified.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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