OCTOPUS NUVO TISSUE STABALIZER

Description of Event or Problem

MEDTRONIC CARDIOVASCULAR RECEIVED INFORMATION THAT DURING MINIMALLY INVASIVE CORONARY ARTERY BYPASS, THIS OCTOPUS NUVO DEVICE EXHIBITED A POPPING SOUND. THE COLLET THAT ATTACHES TO THE SHAFT OF THE HANDLE AND THAT HOLDS THE HEADLINK STABLE, HAD FRACTURED. AT THE SAME TIME, THE WHALE TAIL AND INTERNAL DEVICE SHAFT LOOSENED AND SLID OUT FROM THE HANDLE. THE HEADLINK COLLET, IT WAS DETERMINED, HAD FRACTURED INTO THREE SEPARATE PIECES; ONE THAT REMAINED WITHIN THE SHAFT, ONE THAT WAS RETRIEVED JUST OUTSIDE OF THE THORACOTOMY INCISION, AND ONE THAT WAS RETRIEVED WITHIN THE CHEST CAVITY ONCE LOCATED BY X-RAY. THERE WAS OTHERWISE NO PATIENT HARM. DESPITE THIS FRACTURE, THE HEADLINK ITSELF REMAINED IN POSITION, AND THE SURGEON COMPLETED THE PROCEDURE.

Additional Manufacturer Narrative

(B) (4). ANALYSIS: VISUAL INSPECTION SHOWED, THE THREE FINGERS WERE BROKEN OFF AND RETURNED LOOSE INSIDE THE BAG WHEN RECEIVED. THE FOURTH PIECE WAS RETAINED INSIDE THE SHAFT ASSEMBLY. PERFORMANCE TESTING WAS PERFORMED ON A RESERVE DEVICE, AS TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGE OF THE RETURNED PRODUCT. THE DEVICE WAS SENT FOR EVALUATION OF THE MATERIAL INTEGRITY AND FOUND TO BE WITHIN SPECIFICATION. MULTIPLE ATTEMPTS WERE MADE TO RECREATE THE CLINICAL OBSERVATIONS. THE COLLET FRACTURE WAS RECREATED BY TIGHTENING THE WHALE TAIL TO A TORQUE OF 100 INCH POUNDS. THIS COULD ONLY BE ACHIEVED BY PLACING THE DEVICE IN A VICE AND TIGHTENING WITH A WRENCH. REVIEW OF MANUFACTURING RECORDS FOR THIS PRODUCT DID NOT REVEAL ANY ABNORMALITIES OR NON-CONFORMANCES.