Only the packaging components were returned and unused.The packaging was not returned.A catheter tubing kink was found at 27.94 cm from the iab tip.Unable to complete visual and chemical inspection of the packaging for silicone migration since it was not returned.Since the packaging was not returned, we are unable to confirm the reported problem.However, intra-aortic balloon catheters and some insertion kit components manufactured by datascope corp.Require medical grade silicone lubricant during manufacturing, and some lubricant may also be used as a surface coating to insure smooth insertion for small french size devices.Thus, it is possible that small spots (ranging from not visible to being visually obvious) of migrated lubricant may appear between the tray and the clear tray cover.This silicone is not foreign matter, is biocompatible and does not affect or compromise sterility of the intra-aortic balloon catheters or insertion kits.Non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period jun-2019 through may-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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