THD REVOLUTION

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED FOR TECHNICAL INVESTIGATION. BASED ON THE PRODUCT ANALYSIS RESULTS, THE ROOT CAUSE ANALYSIS OF THE FAILURE IS A COLD SOLDER JOINT WITHIN THE DEVICE, IN PARTICULAR ON THE DOPPLER PROBE CONNECTOR TRANSDUCER CABLE. THE INVESTIGATION OF THE COMPLAINT WITH REFERENCE TO THE MANUFACTURING RECORDS FOUND THAT THE IN THE FINAL TESTS PERFORMED BEFORE THE RELEASE OF THE DEVICE FOR DISTRIBUTION, THE DOPPLER SIGNAL COULD BE REGULARLY HEARD AND NO ANOMALIES WERE FOUND. COMPLAINTS TREND ANALYSIS FOUND ONLY TWO SIMILAR EVENTS, ONE OCCURRED IN 2015 AN THE OTHER IN 2019, FOR THE SAME DEVICE AND REPORTED, RESPECTIVELY, WITH MFR REPORT #3006680097-2015-007, AND #3006680097-2019-00002. WE EMPHASIZE THAT THE DEVICE WAS MANUFACTURED IN 2014, AND THE PROBLEM OCCURRED AFTER SEVERAL HOURS OF OPERATION OF THE DEVICE, WHICH HAD NEVER BEFORE EXPERIENCED ANY PROBLEMS. FURTHERMORE, THE DEVICE WAS MANUFACTURED BEFORE THE DATE OF THE FIRST REPORT (MFR REPORT #3006680097-2015-007), AFTER WHICH A MONITORING ACTION WAS OPENED ON ALL NEWLY PRODUCED DEVICES AND NO ANOMALIES HAVE BEEN FOUND, ON THESE DEVICES, UP TO DATE. WE THEREFORE CONSIDER THE EVENT A RARE AND ISOLATED PROBLEM COMPATIBLE WITH A MANUFACTURING DEFECT OF THE CONNECTOR NOT DETECTABLE AT THE TIME OF THE PRODUCTION CHECKS, BUT HIGHLIGHTED ONLY AFTER USE OF THE DEVICE OVER TIME. THE MONITORING ACTIVITY ON NEW DEVICES IS CARRIED OUT ROUTINELY. SHOULD WE GET FURTHER INFORMATION, ADDITIONAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

DURING A THD INTERVENTION, ONCE THE DOPPLER PROBE WAS CONNECTED TO THD REVOLUTION DEVICE, NO DOPPLER SOUND COULD BE HEARD. THE STAFF TRIED TO MOVE THE DOPPLER PROBE FROM SIDE TO SIDE AND CHANGED THE PROBE ITSELF IN ORDER TO GET THE DOPPLER SOUND WITHOUT SUCCESS. THD REVOLUTION WAS TESTED IN ANOTHER ROOM/OFFICE, BUT THE SAME ISSUE WAS EXPERIENCED. THE STAFF DECIDED TO TERMINATE THE SURGERY, THUS THE PATIENT WAS NOT TREATED AND WAS DISCHARGED WITHOUT ANY CONSEQUENCES.