HERCULES III

Additional Manufacturer Narrative

TERUMO HAS RECEIVED THE DEVICE FOR EVALUATION; HOWEVER, 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). RESULTS: RESULTS PENDING COMPLETION OF EVALUATION. CONCLUSIONS: CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS.

Description of Event or Problem

THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT AFTER CARDIOPULMONARY BYPASS, AN ABRASION WAS DISCOVERED ON THE HEART. PER USER FACILITY THE DISTAL END/ LIP OF THE UNIT WAS SHARP/ ABRASIVE AND IT RUBBED AND CREATED AN ABRASION ON THE HEART. THERE WAS A DELAY FOR LESS THAN A MINUTE; PRODUCT WAS CHANGED OUT; PROCEDURE WAS COMPLETED SUCCESSFULLY.

Description of Event or Problem

THERE WAS A 15 MINUTES DELAY. PRODUCT WAS NOT CHANGED OUT.

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 12, 2018. (B)(4). 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 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.