VERSACROSS CONNECT LAAC ACCESS SOLUTION

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: WHEN THE DILATOR WAS RETURNED INVESTIGATORS VISUALLY INSPECTED THE DILATOR AND IT WAS FOUND THAT THE IRRIGATION LUER WAS MISSING. DEVICE HISTORY REVIEW: THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. RISK REVIEW: A REVIEW OF THE VERSACROSS' RISK DOCUMENTATION WAS COMPLETED AND CONFIRMED THAT THE EVENT OF A DAMAGED LUER WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE TRACED TO DEVICE DESIGN AND AS THE PACKAGING DESIGN MAY CREATE STRESS POINTS ALONG THE DEVICE THAT CAN CONTRIBUTE TO DAMAGE WHEN THE DEVICE IS REMOVED FROM THE PACKAGING OR LATER AS THE DEVICE IS USED.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE ATTACHING THE SYRINGE TO THE DILATOR TO FLUSH IT, THE LUER LOCK CONNECTION AT THE DILATOR END SNAPPED OFF AND REMAINED ATTACHED TO THE SYRINGE. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO RETURN FOR LABORATORY ANALYSIS. THE SYSTEM WAS RETURNED FOR ANALYSIS AND IT WAS FURTHER DISCOVERED THAT IT WAS THE IRRIGATION LUER HAD DETACHED.