COUPLER

Description of Event or Problem

DURING A SURVEY, AN UNSPECIFIED HEALTHCARE WORKER RESPONDED THAT DURING THE ANASTOMOSIS OF VEINS AND ARTERIES IN MICRO-SURGICAL AND/OR VASCULAR RECONSTRUCTIVE PROCEDURE WITH A COUPLER OR UP TO 12 WEEKS POST-SURGICAL THAT AN UNKNOWN QUANTITY OF PATIENTS DEVELOPED THROMBI. ADDITIONALLY, THE RESPONDENT STATED, ¿THE COMPLICATION OF THROMBOSIS IS WELL RECOGNIZED. IN RETROSPECT THIS COULD HAVE BEEN DUE TO TOO MUCH TENSION APPLIED AT THE TIME OF SURGERY.¿ FURTHERMORE, THE SURVEY INQUIRED ABOUT ANASTOMOTIC PATENCY AND THE SALVAGE OF A COMPROMISED FREE FLAP. THE RESPONDENT STATED, ¿NO NOT IDENTIFIED AT THE TIME OF SURGERY.¿ FURTHERMORE, ¿IT WAS FELT THAT THE FLOW COUPLER DID IN FACT DETECT THE ANASTOMOTIC PATENCY AT THE TIME OF SURGERY, BUT IN THE LONG RUN, SECONDARY TO THROMBOSIS THE GRAFT FAILED. GRAFT FAILED SECONDARY TO THROMBOSIS. ALTHOUGH AT THE TIME OF SURGERY, IT DID NOT APPEAR THERE WAS ANY COMPLICATION.¿ THIS EVENT LIKELY REQUIRED MEDICAL/SURGICAL 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.