H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the crosser cto recanalization catheter products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheter products are identified in d2 and g4.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 14s crosser cto recanalization catheter was returned for evaluation.During visual evaluation, distal tip was noted to be separated from catheter and still attached to the inner core wire.The catheter was noted to be frayed near to the marker band.No functional testing due to the condition of the device.Therefore, the investigation is confirmed for the identified material separation as the distal tip was separated from the catheter.The investigation is also confirmed for the identified material fray issue as the catheter was noted to be frayed near to the marker band.However, the investigation is unconfirmed for the reported detachment issue as the distal tip was not detached fully from the catheter but still attached to the inner core wire.A definitive root cause for the reported tip detachment and identified material separation and material fray issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 03/2024), g3, h6 (device, method).H11: section a through f - the information provided by bd 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 bd.
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