After opening the packaging of 2 7f maxi ld 110 20x40 percutaneous transluminal angioplasty (pta) catheters, the user found the inner sterile packaging was ¿leaking.¿ the devices will be returned for analysis.There was no reported patient injury.When removing the package, it was noted that the inner package leaked before being used.The seal of the inner package was not was opened.The product was stored in the lab.The actual product was not damaged.The product was not used.
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After opening the packaging of 2 7f maxi ld 110 20x40 percutaneous transluminal angioplasty (pta) catheters, the user found the inner sterile packaging was ¿leaking.¿ there was no reported patient injury.When removing the package, it was noted that the inner package leaked before being used.The seal of the inner package was not opened.The product was stored in the lab.The actual product was not damaged.The product was not used.Case-(b)(4): two non-sterile unit of maxi ld pta f7 110 20x40 were received coiled inside a plastic bag.No original inner/outer packaging was returned for analysis.The device identified as number 1 was assigned to this product evaluation file.Device # 1 was visually inspected and several kink/bent conditions were observed at 24, 54, 86 and 88 cm from the distal tip.No other damages or anomalies were found.A device history record (dhr) review of lot 17705610 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box compromised sterility sterile barrier breached¿ could not be confirmed through analysis of the returned devices since the products¿ inner pouches were not received.The exact cause of the issue experienced by the customer could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the issue experienced by the customer.However, the kinked conditions found may be due to handling during shipping for analysis since none of the packaging was received.As warned in the instructions for use, which is not intended as a mitigation, ¿do not use open or damaged packages.¿ neither the product analyses nor the dhr reviews suggests that the event reported could be related to the manufacturing process.Therefore, no corrective/preventive actions will be taken at this time.This is one of two products associated with the reported event and the related report number is 9616099-2018-02396.
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