A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803.The device history records have been reviewed with special attention to the raw materials, the subassemblies, the manufacturing process and the quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this failure mode.The device was returned.The investigation is confirmed for a split, which was likely perceived by the customer as a puncture in the balloon.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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