OUTBACK

Additional Manufacturer Narrative

AS REPORTED, THE 80 CM OUTBACK RE-ENTRY CATHETER EXPERIENCED A FAILURE WHEN THE WIRE PROTRUDED PERPENDICULARLY THROUGH THE NEEDLE RATHER THAN EXITING THE DISTAL TIP. MULTIPLE WIRES WERE USED DURING THE PROCEDURE, AND THE STAFF BELIEVED THE NON-CORDIS GUIDEWIRE WAS WHAT CAUSED THE ISSUE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A PICTURE RELATED TO THE REPORTED FAILURE WAS PROVIDED BY THE CUSTOMER IN EVENT (B)(4). THE PHOTOGRAPHIC EVIDENCE SHOWS A GUIDEWIRE EXITING PERPENDICULARLY THROUGH THE NEEDLE RATHER THAN ADVANCING THROUGH THE LUMEN TO THE DISTAL TIP, AND THE NEEDLE APPEARS TO BE IN THE DEPLOYED POSITION. THE REPORTED EVENT INDICATES THAT THE 80 CM OUTBACK RE-ENTRY CATHETER EXPERIENCED A FAILURE IN WHICH THE GUIDEWIRE DID NOT EXIT THROUGH THE DISTAL TIP BUT INSTEAD PROTRUDED PERPENDICULARLY THROUGH THE NEEDLE, CONSISTENT WITH THE CONDITION OBSERVED IN THE PROVIDED PHOTOGRAPH. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE CONCLUSIVELY DETERMINED BASED SOLELY ON THE IMAGES; THEREFORE, IT IS NOT POSSIBLE TO ESTABLISH WHETHER THE EVENT WAS RELATED TO THE MANUFACTURING PROCESS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 18469912 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE MALFUNCTION ¿CANNULA/NEEDLE ¿ DEPLOYMENT DIFFICULTY ¿ THROUGH SHAFT¿ WAS NOT OBSERVED DURING THE PHOTO ANALYSIS. INSTEAD, THE IMAGES SHOW A GUIDEWIRE EXITING PERPENDICULARLY THROUGH THE NEEDLE RATHER THAN ADVANCING THROUGH THE LUMEN TO THE DISTAL TIP, WITH THE NEEDLE APPEARING TO BE IN THE DEPLOYED POSITION. BECAUSE THE DEVICE WAS NOT RETURNED, THE EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED. MULTIPLE GUIDEWIRES WERE REPORTEDLY USED DURING THE PROCEDURE. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCT LABELING WITH THE INTENT OF MAKING THE USER AWARE OF POTENTIAL RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE FOLLOWING GUIDEWIRES ARE RECOMMENDED FOR USE WITH THE OUTBACK® ELITE RE-ENTRY CATHETER: 0.014¿ ATW (CORDIS, A CARDINAL HEALTH COMPANY); 0.014¿ STABILIZER® PLUS (CORDIS, A CARDINAL HEALTH COMPANY); 0.014¿ STABILIZER® XS (CORDIS, A CARDINAL HEALTH COMPANY); 0.014¿ CHOICE EXTRA SUPPORT (BOSTON SCIENTIFIC/SCIMED); 0.014¿ MAILMAN (BOSTON SCIENTIFIC/SCIMED); AND 0.014¿ LUGE (BOSTON SCIENTIFIC/SCIMED). FAILURE TO USE A RECOMMENDED GUIDEWIRE MAY RESULT IN DAMAGE TO THE GUIDEWIRE, SUCH AS ABRASION OF THE HYDROPHILIC COATING, RELEASE OF POLYMER FRAGMENTS, SEPARATION OF THE WIRE, OR INABILITY TO WITHDRAW THE OUTBACK® ELITE RE-ENTRY CATHETER OVER THE GUIDEWIRE. BASED ON THE AVAILABLE INFORMATION AND PRODUCT ANALYSIS, THERE IS NO EVIDENCE TO SUGGEST THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem

AS REPORTED, THE 80 CM OUTBACK RE-ENTRY CATHETER EXPERIENCED A FAILURE WHEN THE WIRE PROTRUDED PERPENDICULARLY THROUGH THE NEEDLE RATHER THAN EXITING THE DISTAL TIP. MULTIPLE WIRES WERE USED DURING THE PROCEDURE, AND THE STAFF BELIEVES THE NON-CORDIS GUIDEWIRE WAS WHAT CAUSED THE ISSUE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION.