HERCULES III

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS. THE RETURNED SAMPLE WAS VISUALLY INSPECTED UPON RECEIPT, AND THE INVESTIGATION VERIFIED DAMAGE TO THE DISTAL END OF THE HERCULES III ARM WHERE THE ATTACHMENTS ARE CONNECTED. A RETENTION SAMPLE IS NOT APPLICABLE FOR THIS IS AN INDIVIDUALLY SERIALIZED AND RELEASED FOR DISTRIBUTION. ALL HERCULES UNIVERSAL STABILIZER ARMS ARE VISUALLY INSPECTED FOR DAMAGE PRIOR TO RELEASE; THEREFORE, IT IS LIKELY THAT THE UNIT WAS EXPOSED TO A SHOCK FORCE AFTER MANUFACTURING THAT CAUSED THE ABRASIVE EDGE. IT WAS NOT ABLE TO BE DETERMINED HOW OR WHEN THE DAMAGE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON JULY 02, 2018. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

Additional Manufacturer Narrative

TERUMO HAS NOT RECEIVED THE DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4)

Description of Event or Problem

THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE DISTAL END OF THE HERCULES ARM IS SHARP AND ABRASIVE WHICH CAUSED AN ABRASION IN THE HEART WHILE DOING THE PROCEDURE. THERE WAS A ABOUT A 15 MINUTE DELAY TO REPAIR THE ABRASION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME ARM AS IT WAS FIXED BY PUTTING A SEAL ON THE UNIT. *NO BLOOD LOSS, *PRODUCT WAS NOT CHANGED OUT, *PROCEDURE WAS COMPLETED SUCCESSFULLY.