AXIOM ATRAUM WITH CLOT STOP THORACIC ANGLE SILICONE CATHETER

Additional Manufacturer Narrative

THIS COMPLAINT IS WITHIN THE SCOPE OF CAPA (B)(4). DEVICE WAS DISCARDED BY HEALTHCARE FACILITY AND WAS NOT RETURNED TO THE MANUFACTURER. COMPLAINT LOG F-1B HAS BEEN REVIEWED FOR OTHER RELEVANT OR SIMILAR EVENTS. REFERENCE COMPLAINT NUMBERS AND MAKE NOTES AS NECESSARY TO DESCRIBE RELEVANCE: SALES HISTORY FOR ITEM 111120AT, LOT 1802384R, BOWERS, 1 BOX, 11-13-18 , CARDIOMEDICS, 6 BOXES, 7-13-18 AND 9-17-18, LONG BEACH MEMORIAL, 1 BOX, 10-17-18, TRI-ANIM, 9 BOXES, 6-29-18, 7-19-18, AND 2-7-19. NO COMPLAINT OTHER THAN FROM NICKLAUS CHILDREN'S HOSPITAL (TRI-ANIM) SAMPLES TESTED FROM SAME LOT PERFORMED TO SPECIFICATION AFTER BEING SOAKED PER INSTRUCTIONS ON LABEL. THE REVIEW OF IN-PROCESS CONTROLS AND REVIEW OF DEVICE FEEDBACK SUPPORT THE CONCLUSION THAT THIS IS AN ISOLATED ISSUE. THE 'CRYSTALS' REFERENCED IN THE COMPLAINT DESCRIPTION REFERS TO THE COATING BEFORE IT IS LUBRICATED, SUGGESTING THAT THE USER DID NOT SOAK THE CATHETERS PRIOR TO USE. BASED ON AVAILABLE INFORMATION, THE LIKELY ROOT CAUSE IS RELATED TO USER ERROR - NOT SOAKING THE CATHETERS PER INSTRUCTIONS. DUE TO ESG ISSUES, REPORTING WAS DELAYED TO (B)(6) 2021. ON (B)(6) 2021, A TICKET (B)(4) WAS OPENED REQUESTING WEB TRADER ACCOUNT SETUP. VERIFICATION EMAIL WAS NEVER RECEIVED AFTER INITIAL REGISTRATION. THERE HAVE BEEN TECHNICAL DIFFICULTIES GETTING A SECONDARY TEST ACCOUNT AND COMMUNICATION WITH THE ESG HELP DESK IS ONGOING AS OF DUE DATE (B)(6) 2021.

Description of Event or Problem

CUSTOMER STATED CRYSTALLIZED MATERIAL FORMED INSIDE THE TUBE CAUSING NARROWING OF THE INNER LUMEN. CUSTOMER FLUSHED THE CATHETER WITH PLASMA-LYTE SOLUTION, PH 7.4. FOLLOWING THE FLUSH, THE PATIENT EXPERIENCED TAMPONADE. THE CUSTOMER IS CONCERNED THE CRYSTALS IN THE TUBE WERE THE CAUSE OF THE TAMPONADE.

Description of Event or Problem

CUSTOMER STATED CRYSTALLIZED MATERIAL FORMED INSIDE THE TUBE CAUSING NARROWING OF THE INNER LUMEN. CUSTOMER FLUSHED THE CATHETER WITH PLASMA-LYTE SOLUTION, PH 7.4. FOLLOWING THE FLUSH, THE PATIENT EXPERIENCED TAMPONADE. THE CUSTOMER IS CONCERNED THE CRYSTALS IN THE TUBE WERE THE CAUSE OF THE TAMPONADE.

Additional Manufacturer Narrative

THIS COMPLAINT IS WITHIN THE SCOPE OF CAPA (B)(4). DEVICE WAS DISCARDED BY HEALTHCARE FACILITY AND WAS NOT RETURNED TO THE MANUFACTURER. COMPLAINT LOG F-1B HAS BEEN REVIEWED FOR OTHER RELEVANT OR SIMILAR EVENTS. REFERENCE COMPLAINT NUMBERS AND MAKE NOTES AS NECESSARY TO DESCRIBE RELEVANCE: SALES HISTORY FOR ITEM 111120AT, LOT 1802384R, BOWERS, 1 BOX, 11-13-18 , CARDIOMEDICS, 6 BOXES, 7-13-18 AND 9-17-18, LONG BEACH MEMORIAL, 1 BOX, 10-17-18, TRI-ANIM, 9 BOXES, 6-29-18, 7-19-18, AND 2-7-19. NO COMPLAINT OTHER THAN FROM NICKLAUS CHILDREN'S HOSPITAL (TRI-ANIM) SAMPLES TESTED FROM SAME LOT PERFORMED TO SPECIFICATION AFTER BEING SOAKED PER INSTRUCTIONS ON LABEL. THE REVIEW OF IN-PROCESS CONTROLS AND REVIEW OF DEVICE FEEDBACK SUPPORT THE CONCLUSION THAT THIS IS AN ISOLATED ISSUE. THE 'CRYSTALS' REFERENCED IN THE COMPLAINT DESCRIPTION REFERS TO THE COATING BEFORE IT IS LUBRICATED, SUGGESTING THAT THE USER DID NOT SOAK THE CATHETERS PRIOR TO USE. BASED ON AVAILABLE INFORMATION, THE LIKELY ROOT CAUSE IS RELATED TO USER ERROR - NOT SOAKING THE CATHETERS PER INSTRUCTIONS. DUE TO ESG ISSUES, REPORTING WAS DELAYED TO (B)(6) 2021. ON (B)(6) 2021, A TICKET 275008 WAS OPENED REQUESTING WEB TRADER ACCOUNT SETUP. VERIFICATION EMAIL WAS NEVER RECEIVED AFTER INITIAL REGISTRATION. THERE HAVE BEEN TECHNICAL DIFFICULTIES GETTING A SECONDARY TEST ACCOUNT AND COMMUNICATION WITH THE ESG HELP DESK IS ONGOING AS OF DUE DATE (B)(6) 2021.