THE PRODUCT WAS NOT RETURNED. MANUFACTURING AND QUALITY CONTROL DATA - WITHOUT A SERIAL NUMBER IT IS NOT POSSIBLE FOR US TO RETRACE THE COMPLAINED PRODUCT. COMPLAINT HISTORY - THIS IS THE FIRST COMPLAINT ABOUT A TITANIUM CONNECTOR IN OUR HISTORY OVER THE PAST 4 YEARS. RESULT - AN INVESTIGATION WAS NOT POSSIBLE BECAUSE NO PRODUCT WAS AVAILABLE. BASED ON THE COMPLAINT DESCRIPTION IT IS NOT CLEAR WHAT CAUSED THE MALFUNCTION. THEREFORE, WE CANNOT CLARIFY WHAT MAY HAVE INFLUENCED THE PRODUCT CONDITION, AS THIS WOULD REQUIRE AN INVESTIGATION OF THE CONNECTOR. NO FURTHER ACTIONS ARE REQUIRED.
D
Patient 1
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE SHUNT SYSTEM. THE PATIENT WAS INITIALLY IMPLANTED ON AN UNSPECIFIED DATE. SOMETIME AFTER THE IMPLANTATION, THE SYMPTOMS OF THE PATIENT WERE "NOT SO WELL" AND VENTRICULAR ENLARGEMENT WAS CONFIRMED. SO, THE SURGEON TRIED TO ADJUST THE PRESSURE TO 0CM BUT IT DID NOT IMPROVE. AFTER THIS, THE SURGEON TOOK OUT THE PROGAV AND IMPLANTED ANOTHER COMPANY'S PRODUCT INSTEAD. THE SURGEON NOTED THAT PERHAPS THE SIZE OF THE PRODUCT HAD NOT BEEN APPROPRIATE TO THE PATIENT WHEN HE CHOSE THE PRODUCT. ALSO, THE SURGEON DID NOT TRY TO FLASH SINCE HE HAD NO IDEA THAT THE PRODUCT WAS ABLE TO BE FLASHED. THERE WAS NO BLOCKAGE FOUND WITHIN THE CATHETER THAT WAS TAKEN OUT AT THE SAME TIME AS THE VALVE. A REVISION WAS PERFORMED DUE TO THE MALFUNCTION. ADDITIONAL INFORMATION WAS NOT PROVIDED. ASSOCIATED MEDWATCHES: 3004721439-2020-00064.
Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)