H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 6s crosser cto recanalization catheter was returned for evaluation.During visual evaluation, it was noted that the distal tip was detached from the catheter along with marker band and not returned.The inner core wire had a break approximately 4.1cm from the distal end of the catheter.No functional testing due to the condition of the sample.Therefore, the investigation is confirmed for the detachment of device or device component and corewire fracture.A definitive root cause for the detachment of device or device component and corewire fracture could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 09/2022).H11: section a through f: the information provide by bd represents all 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 bd.
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