THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. ALL AVAILABLE INFORMATION WAS INVESTIGATED AND THE REPORTED DIFFICULT TO INSERT (ANATOMY) WAS A RESULT OF CHALLENGING ANATOMY AND OPERATIONAL CONTEXT. THE REPORTED DEFORMATION DUE TO COMPRESSIVE STRESS (SHAFT) WAS A CASCADING RESULT OF THE REPORTED DIFFICULT TO INSERT (ANATOMY). THE REPORTED CABLE BREAK WAS A RESULT OF OPERATIONAL CONTEXT AS IT WAS REPORTED THAT THE NEGATIVE KNOB WAS OVERROTATED ONCE THE SGC WAS REMOVED FROM THE ANATOMY. THE REPORTED AUDIBLE NOISE WAS DUE TO THE REPORTED CABLE BREAK. THERE IS NO INDICATION OF PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.
D
Patient 1
THIS IS BEING FILED TO REPORT THE CABLE BREAK. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. RESISTANCE WAS MET INSERTING THE STEERABLE GUIDE CATHETER (SGC) INTO THE FEMORAL VEIN, RESULTING IN A KINK. THE SGC WAS REMOVED. THE NEGATIVE KNOB WAS TURNED PAST ? AND A POP WAS HEARD, THE CABLE WAS NOTED TO BE BROKEN. THE SGC WAS REPLACED WITH A NEW ONE AND TWO CLIPS WERE IMPLANTED, REDUCING MR TO 2. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS.