GM-30 ACCESSORY KIT

Description of Event or Problem

BLOOD LEAKAGE WAS REPORTED DURING THE PROCEDURE. THE GM-30 ACCESSORY KIT WAS USED, AND LEAKAGE WAS OBSERVED AT THE Y-CONNECTOR. THE DEVICE WAS SUBSEQUENTLY REPLACED WITH AN IDENTICAL NEW DEVICE, AND THE PROCEDURE WAS CONTINUED. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

AS A RESULT OF THE PRODUCT INVESTIGATION, NO ABNORMALITIES WERE FOUND IN THE PRODUCT. BOTH THE HEMOSTASIS VALVE AND THE FIXED VALVE WERE FUNCTIONING NORMALLY, AND NO LEAKAGE WAS OBSERVED AT THE TIME OF THE INVESTIGATION. THE PRODUCT LOT NUMBER HAS NOT BEEN PROVIDED FROM THE CUSTOMER. THEREFORE, AN INVESTIGATION BASED ON MANUFACTURING RECORDS COULD NOT BE CONDUCTED. THE REPORTED EVENT MAY HAVE BEEN ATTRIBUTED TO THE INSERTION STATUS OF THE COMBINED DEVICES OR TO UNINTENTIONAL MISLOCKING OF THE OPENER; HOWEVER, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) PROVIDE GENERAL INSTRUCTIONS FOR USE, WARNINGS AND PRECAUTIONS RELATED TO THE DEVICE, AND INFORMATION TO MAKE USERS AWARE OF POTENTIAL COMPLICATIONS AND OTHER EVENTS SIMILAR TO THIS EVENT THAT MAY OCCUR. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE PRODUCT IS DEFECTIVE. ALTHOUGH THE INVESTIGATION FOUND NO ABNORMALITIES IN THE PRODUCT, IT CANNOT BE CONFIRMED THAT NO LEAKAGE OCCURRED FROM THE PRODUCT DURING CLINICAL USE. THEREFORE, AS BLOOD LEAKAGE MAY LEAD TO AN ADVERSE EVENT, THIS CASE IS BEING REPORTED IN ACCORDANCE WITH 21 CFR PART 803.50(A)(2).