HEMOGLIDE HEMODIALYSIS CATHETER

Description of Event or Problem

A GROUP OF PATIENTS UNDERWENT FOR RETROSPECTIVE COHORT STUDY IN WHICH ALL ADULT PATIENTS RECEIVED TCS (TUNNELED CATHETERS) FOR HD (HEMODIALYSIS) THAT WERE IMPLANTED FROM 2005 TO 2019 AT THE (B)(6) HOSPITAL. A RETROSPECTIVE COHORT STUDY (2005 TO 2019) FROM (B)(6) HOSPITAL EVALUATED TUNNELED HEMODIALYSIS CATHETERS, INCLUDING THE PALINDROME AND HEMOGLYDE. A TOTAL OF 462 CATHETERS WERE IMPLANTED IN 381 PATIENTS, WITH 325 PATIENTS ULTIMATELY ANALYZED. EIGHTY-FIVE CATHETER RELATED BLOODSTREAM INFECTIONS (0.36/1,000 CATHETER/DAYS) WERE REPORTED, PREDOMINANTLY CAUSED BY GRAM POSITIVE ORGANISMS SUCH AS STAPHYLOCOCCUS EPIDERMIDIS AND S. AUREUS. MOST INFECTIONS OCCURRED AFTER 6 MONTHS OF PLACEMENT. AT THE END OF THE STUDY PERIOD, A TOTAL OF 246 PATIENTS (75.6%) HAD DIED FROM VARIOUS CAUSES, INCLUDING INFECTION, CARDIAC DISEASE, NEOPLASMS, STROKE OR INTRACRANIAL HEMORRHAGE, CESSATION OF HEMODIALYSIS DUE TO HIGH COMORBIDITY, AND OTHER DIGESTIVE ETIOLOGIES. INFECTION WAS IDENTIFIED AS THE MOST COMMON CAUSE OF DEATH.

Additional Manufacturer Narrative

H11: DATE OF DEATH FOR THIS PATIENT WAS NOT PROVIDED, DATE OF DEATH UPDATED AS (B)(6) 1900 FOR THE MDR SUBMISSION REQUIREMENT. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW UP REPORT WILL BE SUBMITTED AS APPLICABLE. SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.