COUPLER

Description of Event or Problem

DURING A SURVEY, AN UNSPECIFIED HEALTHCARE WORKER RESPONDED TO THE QUESTION REGARDING ANY ADVERSE EVENTS OCCURRED EITHER DURING THE ANASTOMOSIS OF VEINS AND ARTERIES IN MICRO-SURGICAL AND/OR VASCULAR RECONSTRUCTIVE PROCEDURE WITH A COUPLER OR UP TO 12 WEEKS FOLLOWING THE PROCEDURE AS ¿AT THE TIME OF THE PROCEDURE - DIFFICULTY WITH BLEEDING NOTED AT THE ANASTOMOTIC SITE, PARTLY IATROGENIC, PARTLY ALSO BECAUSE THE DEVICE DID NOT SEAL PROPERLY DURING INSERTION.¿ WHEN ASKED IF THE SURGEON ACHIEVED PATENCY USING THE COUPLER, THE RESPONDENT STATED, ¿GRAFT FAILED FOR REASONS STATED.¿ THE FOLLOWING QUESTION DID THE FLAP CREATED USING THE SYNOVIS GEM FLOW COUPLER SURVIVE? THE RESPONDENT REPLIED ¿NO, A LOT OF BLEEDING NOTED AT THE ANASTOMOTIC SITE; PARTLY SURGICAL ERROR, BUT ALSO IT MAY BE THAT THE DEVICE DID NOT SEAL PROPERLY DURING PLACEMENT - AGAIN A RECOGNIZED COMPLICATION." THESE EVENTS LIKELY REQUIRED MEDICAL INTERVENTION IN ORDER TO PRECLUDE PERMANENT IMPAIRMENT. THE RESPONDENT ANSWERED ANONYMOUSLY; THEREFORE, FOLLOW UP INFORMATION WAS NOT ABLE TO BE OBTAINED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.