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.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.It was noted the distal tip was detached from the catheter and was not returned with sample.The distal marker band was attached.Distal tip detachment measures 145.5 cm from break to strain relief.Based on the findings, the investigation is confirmed for the reported tip detachment issue as it was noted that the distal tip was detached from the catheter.A definitive root cause for the reported detachment issue could not be determined based upon the provided information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date: 01/2023 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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