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.The sample appeared to have blood residue throughout.The distal tip was separated from the outer catheter but still attached to the inner core wire.The distal marker band was attached.No kinks noted to the catheter, no anomalies noted to transducer handle, saline hub, or distal tip.Marker band is present and undamaged.Material separation also noted just below the distal tip.Therefore, the investigation is confirmed for alleged material separation issue as the distal tip was separated from the outer catheter but still attached to the inner core wire.A definitive root cause for the alleged material separation issue 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.The catalog number identified in section d4 has not been cleared in the us but is similar to the crosser cto recanalization catheters products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheters products are identified in d2 and g5.Expiry date: 05/2022.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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