A manufacturing review could not be performed as the lot number is unknown.The device has not been returned to the manufacturer for evaluation.The investigation is currently underway.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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A complete manufacturing review could not be conducted as the lot number is unknown.The investigation is inconclusive, as the sample was not returned for evaluation.Per the reported event details, there were 15 events from the same user over a short period of time where the guidewires melted to the catheters during activation.The user's flowmate injector and generator were replaced with new units and the problem has not been experienced since.Therefore, it is possible that the flowmate injector and/or the generator contributed to the reported events.However, based upon the available information the definitive root cause is unknown.
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