AV SHEATH TUNNELER

Additional Manufacturer Narrative

H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H11: 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.

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT FOR AV SHEATH TUNNELER PROCEDURE. DURING THE PROCEDURE, THE MEDIUM CURVE ROD THAT CREWS INTO IT BECAME STUCK IN THE HANDLE AND A PORTION OF THE THREADED PART (OF VSTR 120) BROKE OFF INSIDE THE HANDLE UPON TRYING TO REMOVE IT AND THE ROD WAS NOT THREADED PROPERLY INTO THE HANDLE AND UNABLE TO GET IT OUT. THE DEVICE WAS ALLEGEDLY SNAPPED OFF INSIDE THE HANDLE. ANOTHER ROD AND HANDLE WERE USED TO COMPLETE THE PROCEDURE.

Description of Event or Problem

ON (B)(6), DURING THE AV SHEATH TUNNELER PROCEDURE IN ESRD, FISTULA CREATION, THE ROD WAS NOT THREADED PROPERLY INTO THE HANDLE AND UNABLE TO GET IT OUT. THE MEDIUM CURVE ROD THAT CREWS INTO IT BECAME STUCK IN THE HANDLE AND A PORTION OF THE THREADED PART BROKE OFF INSIDE THE HANDLE UPON TRYING TO REMOVE IT. THE DEVICE WAS ALLEGEDLY SNAPPED OFF INSIDE THE HANDLE. ANOTHER ROD AND HANDLE WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: A MANUFACTURING LOT REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. THREE ELECTRONIC PHOTOS WERE PROVIDED AND REVIEWED. THE FIRST PHOTO SHOWS AN AV SHEATH TUNNELLER HANDLE AND ONE 120-DEGREE ROD PLACED ON THE FLAT SURFACE. THE ONE SIDE THREADING OF THE 120-DEGREE ROD WAS NOTED TO BROKEN (THE THREADS SHOULD CONTINUE ON BOTH SIDE TO A PORTION OF THE ROD WITH THE HOLE. WHICH WE DO NOT SEE IN THE PROVIDED IMAGE). THE SECOND PHOTO SHOWS THE CASSETTE WITH EMPTY SPACE WHERE HANDLE CAN BE PLACED, AND IT ALSO SHOWS THE MATERIAL NUMBER FOR THAT HANDLE. THE THIRD PHOTO SHOWS THE CASSETTE WITH EMPTY SPACE WHERE 120-DEGREE ROD CAN BE PLACED, AND IT ALSO SHOWS THE MATERIAL NUMBER FOR THAT ROD. NO OTHER VISUAL ANOMALIES WERE NOTED. BASED ON THE PHOTO REVIEW THE REPORTED FAILURE TO DISCONNECT CAN BE CONFIRMED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FAILURE TO DISCONNECT AS THE ROD BROKE WHILE TRYING TO DISCONNECT. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED CRACK SINCE WE DO NOT KNOW IF THERE IS ANY OTHER CRACKING DAMAGE TO THE THREADS OR THE REST OF THE HANDLE. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED CRACK AND FAILURE TO DISCONNECT COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. B5, G3, H6 (DEVICE, METHOD, RESULT, CONCLUSION). 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.