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Patient 1
WE HAVE RECEIVED AND EVALUATED THE COMPLAINT DEVICE. THE DEVICE OPERATED AS EXPECTED AND WE COULD NOT REPLICATE THE DEFECT AS SHOWN IN THE PICTURE PROVIDED BY OUR SALES REP IN (B)(4). ALL OF THE CENTERING HOOPS WERE ABLE TO INSERT INTO THE SHEATH AND THE BLADES ENTERED AND EXITED THE RETAINER AS EXPECTED. THE GAP BETWEEN THE END OF THE RETAINER AND THE TIP OF THE SHEATH WAS HIGHER THAN OUR SPECIFICATION BY 1MM. HOWEVER, ALL OF THE CENTERING HOOPS WERE ABLE TO INSERT INTO THE SHEATH. EVEN WHEN WE COILED THE DEVICE AND TRIED TO REPLICATE THE DEVICE, THE DEVICE OPERATED AS EXPECTED. WE HAVE CONDUCTED A LOT HISTORY REVIEW AND DID NOT FIND ANY ISSUES NOTED IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS ISSUE. ALL QC TESTS PASSED THEIR REQUIREMENTS. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT. HENCE, WE CONSIDER THIS TO BE AN ISOLATED INCIDENT. AT THIS TIME, WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE DEFECT SINCE WE COULD NOT REPLICATE THE DEFECT AS SHOWN IN THE PICTURE. IT IS POSSIBLE THAT THE SILICONE COATING THAT IS USED TO LUBRICATE THE WIRE TO REDUCE FRICTION BETWEEN THE SHEATH AND THE WIRE WAS NOT COATED PROPERLY. AS A RESULT, THE FRICTION PREVENTED THE CENTERING HOOPS FROM CLOSING COMPLETELY INTO THE SHEATH. IT IS ALSO POSSIBLE THAT THE DEVICE WAS EXCESSIVELY COILED WHICH COULD HAVE LET TO THIS FAILURE. OUR IFU DOES WARNS THE USER NOT TO OPEN OR CLOSE THE DEVICE IN A COILED CONFIGURATION. DEVICE WAS TESTED BEFORE USE AND WAS FOUND TO BE OPERATIONAL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THE OPERATION WAS COMPLETED SUCCESSFULLY BY USING THE SAME CATHETER.