OUTBACK RE-ENTRY CATHETER
Report
- Report Number
- 9616099-2011-00482
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 15, 2011
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- DQY
- PMA / PMN Number
- K043534
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
THE PREVIOUSLY SUBMITTED CONCLUSION HAS BEEN AMENDED TO REFLECT ANALYSIS OF THE RETURNED DEVICE. THE INFORMATION RECEIVED INDICATED THAT THE TIP OF THE NEEDLE BROKE WHEN THE PRODUCT WAS BEING USED IN THE PATIENT. THE BROKEN NEEDLE DID NOT SEPARATE INTO TWO PIECES. EVERYTHING WAS RETRIEVED FROM THE PATIENT. THE PHYSICIAN TRIED MANIFOLD AT THE TIME TO DEPLOY THE NEEDLE AND HE FELT AN ELASTIC RESISTANCE. THE PHYSICIAN DID NOT REALIZE THE MOMENT OF THE BREAKING OF THE OUTBACK TIP. THE DEVICE WAS NEARLY 100% PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE. THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. ALL SPECIFIED PORTS WERE FLUSHED. THE PORTS FLUSHED, WERE NOT FOLLOWED BY A 30 SECOND PAUSE, AND THEN FLUSHED AGAIN. HEPARINIZED SALINE WAS USED FOR PREPARATION AND FLUSHING OF ALL PORTS. CANNULA ACTUATION ACTION WAS VERIFIED OUTSIDE OF THE PATIENT. THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION, WITH "NO SLACK" DURING PREPARATION. THE CATHETER WAS NOT COILED PRIOR TO INSERTION. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE USE OF THIS DEVICE. THERE WAS NO INTERVENTION REQUIRED TO TREAT THE ADVERSE EVENT. THERE WAS NO PATIENT INJURY. THE PATIENT IS STABLE. THE CANNULA TIP WAS FULLY RETRACTED BEFORE INSERTION. THE HANDLE DEPLOYMENT SLIDE WAS LOCKED IN THE PROXIMAL POSITION. THERE WAS A ONE TO ONE RESPONSE TO THE NOSECONE WHILE ROTATING THE ROTATING HEMOSTATIC VALVE DURING PREP. PROPER ORIENTATION WAS CONFIRMED UNDER FLUORO PRIOR TO ACTUATION OF THE CANNULA. THERE WAS NO DIFFICULTY ADVANCING THE OUTBACK TO THE LESION, IT WAS VERY EASILY ADVANCED. THE USER DID NOT ENCOUNTER RESISTANCE WHEN TORQUING THE DEVICE. THE DEVICE MADE A "CLICKING SOUND" AND THEN BEGAN TO TURN FREELY WHILE TORQUING WITH NO PROBLEM. THE USER HELD ONTO THE LUER HUB ASSEMBLY LOCATED IN FRONT OF THE BLACK HANDLE WHILE TORQUING THE DEVICE. THE TIP DID NOT GET STUCK IN THE LESION WHILE TORQUING. THERE WAS NO DIFFICULTY/RESISTANCE ACTUATING THE PRODUCT. PROBABLY THE CANNULA WAS NOT POSITIONED CORRECT. ONCE AT THE LESION THE CANNULA/NEEDLE ACTUATED SMOOTHLY. THERE WAS NO RESISTANCE OR DIFFICULTY REMOVING THE OUTBACK FROM THE PATIENT. ABNORMAL FORCE WAS NOT REQUIRED. THE CANNULA WAS RETRACTED PRIOR TO CATHETER WITHDRAWAL. THE PHYSICIAN IS A VERY ACCOMPLISHED USER AND HAS A EXPERIENCE OF MORE THAN 50 INTERVENTIONS A PICTURE OF AN OUTBACK WAS ANALYZED BECAUSE THE UNIT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR ANALYSIS (THE DEVICE HAS NOW BEEN RETURNED AND ANALYSIS IS BELOW). THE PICTURE SHOWED AN OUTBACK INSIDE A POUCH ALREADY OPEN. THE PICTURE SHOWED OUTER SHAFT SEPARATION, THE DISTAL END DOES NOT PRESENT ANY DAMAGE. NO OTHER ANOMALIES WERE OBSERVED IN THE PICTURE. FUNCTIONAL ANALYSIS WAS NOT PERFORMED SINCE DEVICE WAS NOT RETURNED FOR ANALYSIS, ONLY A PICTURE OF THE DEVICE WAS PROPORTIONED. ONE NON STERILE CATHETER OUTBACK WAS RECEIVED COILED INSIDE A PLASTIC BAG. BLOOD RESIDUES WERE NOTED IN THE CATHETER. THE TIP WAS BROKEN AND SEPARATED APPROXIMATED 2.5CM FROM DISTAL TIP END. UNKNOWN STOPCOCK WAS RECEIVED WITH THE RETURNED DEVICE. IT WAS NOT POSSIBLE TO MEASURE THE CANNULA'S USABLE LENGTH DUE TO THE SEPARATION. THE UNIT IS NOT FUNCTIONALLY USABLE. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. FUNCTIONAL ANALYSIS COULD BE NOT PERFORMED DUE TO THE TIP SEPARATION. SEM ANALYSIS WAS PERFORMED TO IDENTIFY THE CAUSE OF BODY SEPARATION; RESULTS SHOWED THAT THE BODY EXTERNAL SURFACE PRESENTED EVIDENCE OF ELONGATION AND SCRATCHING AT THE SURROUNDINGS OF THE SEPARATION. ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL SEPARATION. STRETCHING/ PULLING AND/ OR TWISTING COULD HAVE BEEN RELATED TO THESE SEPARATION CHARACTERISTICS; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE EXACT CAUSE OF THE BODY SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. FAILURE REPORTED BY THE CUSTOMER FOR CANNULA/NEEDLE FRACTURED IN PATIENT WAS CONFIRMED; HOWEVER THE EXACT CAUSE OF CANNULA/NEEDLE FRACTURED IN PATIENT FAILURE COULD BE CONCLUSIVELY DETERMINED: HOWEVER, PROCEDURAL FACTORS COULD CONTRIBUTE TO THE REPORTED FAILURE. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE CANNULA/NEEDLE FRACTURED FROM LEAVING THE FACILITY. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, PROCEDURAL MANIPULATION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THE PRODUCT IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RETURNED YET. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15370246 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15370246. CANNULA SUBASSEMBLY LOTS WERE REVIEWED AND (B)(4). IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE RECORDS WERE ISSUED FOR THESE LOTS. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. BRAIDED CANNULA SUBASSEMBLY WAS REVIEWED AND (B)(4). IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. OUTER SHAFT SUBASSEMBLY LOTS WERE REVIEWED AND (B)(4). IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE RECORDS WERE ISSUED FOR THESE LOTS. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. NOSECONE SUBASSEMBLY LOTS WERE REVIEWED AND (B)(4). IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE RECORDS WERE ISSUED FOR THESE LOTS. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED.
THERE WAS NO DIFFICULTY ADVANCING THE OUTBACK TO THE LESION, IT WAS VERY EASILY ADVANCED. THE USER DID NOT ENCOUNTER RESISTANCE WHEN TORQUING THE DEVICE. THE DEVICE MADE A "CLICKING SOUND" AND THEN BEGAN TO TURN FREELY WHILE TORQUING WITH NO PROBLEM. THE USER HELD ONTO THE LUER HUB ASSEMBLY LOCATED IN FRONT OF THE BLACK HANDLE WHILE TORQUING THE DEVICE. THE TIP DID NOT GET STUCK IN THE LESION WHILE TORQUING. THERE WAS NO DIFFICULTY/RESISTANCE ACTUATING THE PRODUCT. PROBABLY THE CANNULA WAS NOT POSITIONED CORRECT. ONCE AT THE LESION THE CANNULA/NEEDLE ACTUATED SMOOTHLY. THERE WAS NO RESISTANCE OR DIFFICULTY REMOVING THE OUTBACK FROM THE PATIENT. ABNORMAL FORCE WAS NOT REQUIRED. THE CANNULA WAS RETRACTED PRIOR TO CATHETER WITHDRAWAL. THE PHYSICIAN IS A VERY ACCOMPLISHED USER AND HAS EXPERIENCE OF MORE THAN 50 INTERVENTIONS. THE INFORMATION RECEIVED INDICATED THAT THE TIP OF THE NEEDLE BROKE WHEN THE PRODUCT WAS BEING USED IN THE PATIENT. THE BROKEN NEEDLE DID NOT SEPARATE INTO TWO PIECES. EVERYTHING WAS RETRIEVED FROM THE PATIENT. THE PHYSICIAN TRIED IT MANIFOLD AT THE TIME TO DEPLOY THE NEEDLE AND HE FELT AN ELASTIC RESISTANCE. THE PHYSICIAN DID NOT REALIZE THE MOMENT OF THE BREAKING OF THE OUTBACK TIP. THE DEVICE WAS NEARLY 100% PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE. THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. ALL SPECIFIED PORTS WERE FLUSHED. THE PORTS FLUSHED, WERE NOT FOLLOWED BY A 30 SECOND PAUSE, AND THEN FLUSHED AGAIN. HEPARINIZED SALINE WAS USED FOR PREPARATION AND FLUSHING OF ALL PORTS. CANNULA ACTUATION ACTION WAS VERIFIED OUTSIDE OF THE PATIENT. THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION, WITH "NO SLACK" DURING PREPARATION. THE CATHETER WAS NOT COILED PRIOR TO INSERTION. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE USE OF THIS DEVICE. THERE WAS NO INTERVENTION REQUIRED TO TREAT THE ADVERSE EVENT. THERE WAS NO PATIENT INJURY. THE PATIENT IS STABLE. THE CANNULA TIP WAS FULLY RETRACTED BEFORE INSERTION. THE HANDLE DEPLOYMENT SLIDE WAS LOCKED IN THE PROXIMAL POSITION. THERE WAS A ONE TO ONE RESPONSE TO THE NOSECONE WHILE ROTATING THE ROTATING HEMOSTATIC VALVE DURING PREP. PROPER ORIENTATION WAS CONFIRMED UNDER FLUORO PRIOR TO ACTUATION OF THE CANNULA. THERE WAS NO DIFFICULTY ADVANCING THE OUTBACK TO THE LESION, IT WAS VERY EASILY ADVANCED. THE USER DID NOT ENCOUNTER RESISTANCE WHEN TORQUING THE DEVICE. THE DEVICE MADE A "CLICKING SOUND" AND THEN BEGAN TO TURN FREELY WHILE TORQUING WITH NO PROBLEM. THE USER HELD ONTO THE LUER HUB ASSEMBLY LOCATED IN FRONT OF THE BLACK HANDLE WHILE TORQUING THE DEVICE. THE TIP DID NOT GET STUCK IN THE LESION WHILE TORQUING. THERE WAS NO DIFFICULTY/RESISTANCE ACTUATING THE PRODUCT. PROBABLY THE CANNULA WAS NOT POSITIONED CORRECT. ONCE AT THE LESION THE CANNULA/NEEDLE ACTUATED SMOOTHLY. THERE WAS NO RESISTANCE OR DIFFICULTY REMOVING THE OUTBACK FROM THE PATIENT. ABNORMAL FORCE WAS NOT REQUIRED. THE CANNULA WAS RETRACTED PRIOR TO CATHETER WITHDRAWAL. THE PHYSICIAN IS A VERY ACCOMPLISHED USER AND HAS A EXPERIENCE OF MORE THAN 50 INTERVENTIONS A PICTURE OF A (B)(4) WAS ANALYZED BECAUSE THE UNIT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR ANALYSIS. THE PICTURE SHOWED AN OUTBACK INSIDE A POUCH ALREADY OPEN. THE PICTURE SHOWED OUTER SHAFT SEPARATION, THE DISTAL END DOES NOT PRESENT ANY DAMAGE. NO OTHER ANOMALIES WERE OBSERVED IN THE PICTURE. FUNCTIONAL ANALYSIS WAS NOT PERFORMED SINCE DEVICE WAS NOT RETURNED FOR ANALYSIS, ONLY A PICTURE OF THE DEVICE WAS PROPORTIONED. FAILURE REPORTED BY THE CUSTOMER FOR CANNULA/NEEDLE FRACTURED IN PATIENT WAS CONFIRMED; HOWEVER THE EXACT CAUSE OF CANNULA/NEEDLE FRACTURED IN PATIENT FAILURE COULD BE CONCLUSIVELY DETERMINED: HOW EVER PROCEDURAL FACTORS COULD CONTRIBUTE TO THE REPORTED FAILURE. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE CANNULA/NEEDLE FRACTURED FROM LEAVING THE FACILITY. REFER TO MANUFACTURING WORK (B)(4) AND (B)(4). NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE ACTUAL PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.
(B)(4). NO FURTHER DETAILS ARE AVAILABLE AND FURTHER REPORTS ARE NOT EXPECTED AT THIS TIME.
ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE PHYSICIAN TRIED TO MANIFOLD AT THE TIME TO DEPLOY THE NEEDLE AND HE FELT AN ELASTIC RESISTANCE. THE PHYSICIAN DID NOT REALIZE THE MOMENT OF THE BREAKING OF THE OUTBACK TIP. THE DEVICE WAS NEARLY 100% PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE. THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. ALL SPECIFIED PORTS WERE FLUSHED. THE PORTS FLUSHED, WERE NOT FOLLOWED BY A 30 SECOND PAUSE, AND THEN FLUSHED AGAIN. HEPARINIZED SALINE WAS USED FOR PREPARATION AND FLUSHING OF ALL PORTS. CANNULA ACTUATION ACTION WAS VERIFIED OUTSIDE OF THE PATIENT. THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION, WITH "NO SLACK" DURING PREPARATION. THE CATHETER WAS NOT COILED PRIOR TO INSERTION. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE USE OF THIS DEVICE. THERE WAS NO INTERVENTION REQUIRED TO TREAT THE ADVERSE EVENT. THERE WAS NO PATIENT INJURY. THE PATIENT IS STABLE. THE CANNULA TIP WAS FULLY RETRACTED BEFORE INSERTION. THE HANDLE DEPLOYMENT SLIDE WAS LOCKED IN THE PROXIMAL POSITION. THERE WAS A ONE TO ONE RESPONSE TO THE NOSECONE WHILE ROTATING THE ROTATING HEMOSTATIC VALVE DURING PREP. PROPER ORIENTATION WAS CONFIRMED UNDER FLUORO PRIOR TO ACTUATION OF THE CANNULA.
THE INFORMATION RECEIVED INDICATED THAT THE TIP OF THE NEEDLE BROKE WHEN THE PRODUCT WAS BEING USED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OUTBACK RE-ENTRY CATHETER | CTO CATHETER SYSTEMS (DQY) | DQY | CORDIS DE MEXICO | NA | 15370246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |