XCELA
Report
- Report Number
- 3008737795-2024-00001
- Event Type
- Malfunction
- Date Received
- February 14, 2024
- Date of Event
- December 11, 2024
- Report Date
- February 9, 2024
- Manufacturer
- PFM MEDICAL CPP SA
- Product Code
- LJT
- PMA / PMN Number
- K072481
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- 003
Narratives
REVIEW OF DEVICE HISTORY RECORDS: FINISHED GOODS PRODUCT: H965451190, LOT# 153231000. BATCH RECORDS OF LOT# 153231000 IS COMPLETE. NO DEVIATION WAS IDENTIFIED DURING MANUFACTURING. DISCONNECTION FORCE OF CATHETER FROM PORT : 20.55N (ABOVE MIN >10N FOR PUR CATHETER FOLLOWING INC 7030) THE FINISHED GOODS PRODUCT MEETS ITS SPECIFICATION PER MANUFACTURING RECORDS. THIS DEVICE H965451190 IS A FINISHED GOODS WHICH CONTAINS THE FOLLOWING: 61.000.10.268-P : PORT POM CP02 VIOLET ASSEMBLÉ 16-26 PUR 160260-F : PUR CATHETER DIAMETER 1.6X2.6MM CLI 31P : CONNECTOR CLICK 61.000.10.131 : GUIDE 70CM MONTÉ CIAM HUB-HD-2225 : HUBER NEEDLE (LOT# LT-22-0356) 130243: RINSING NEEDLE 406998: VEIN LIFTER 1938 10NS : MICRODARD 8CM, INTÉRIEUR 1MM DSS-012-09 : PTFE TEARAWAY F9 3010.29 : SYRINGE LUER LOCK 10ML 3010.30 : SYRINGE 3PCS 10ML 70020 : TUNNELISEUR CH08 3.0X220. RECORDS FOR INDIVIDUAL COMPONENTS ARE COMPLETE WITH NO RECORDED DEVIATION, WITH THE EXCEPTION OF THE HUBER NEEDLE HUB-HD-2225, LOT# LT-22-0356) FOR WHICH CAPA-23-009 WAS OPENED (SEE INVESTIGATION SECTION BELOW). THE REPORTED DEFECT OF CATHETER MIGRATION IS NOT LINKED TO THE HUBER NEEDLE, NEVERTHELESS THIS COMPLAINT C24009 WILL BE ADDED TO THE SCOPE OF THE CAPA-23-009 FOR EXTENDED BOUNDING & CAPA INVESTIGATION. REVIEW OF NC AND CAPA NO NC AND OR CAPA WAS IDENTIFIED RELATED TO SIMILAR ISSUE (I.E. PORT/CATHETER DISCONNECTION') ON PRODUCT LISTED ABOVE. RETURN PRODUCT VERIFICATION: UNFORTUNATELY, NO MATERIAL WAS RETURNED TO PFM MEDICAL CPP SA. THE VERIFICATION IS THUS LIMITED TO A REVIEW OF THE DHRS AND INSPECTION FILES. THE REPORTED ISSUE PORT CATHETER HAD DISLODGED AND MIGRATED TO THE RIGHT ATRIUM' IS CONSEQUENTLY UNVERIFIABLE. CONCLUSION: THE MOST PROBABLE CAUSE OF THE HEREIN REPORTED PORT CATHETER HAD DISLODGED AND MIGRATED TO THE RIGHT ATRIUM' MIGHT BE DUE TO: MIS-CONNECTION OF THE CATHETER TO THE PORT CONNECTOR PIN MIS-CONNECTION OF THE CLICK CONNECTOR TO SECURE THE CATHETER ON PORT REVIEW OF RECORDED COMPLAINTS: REVIEW OF COMPLAINT FOR PORT/CATHETER DISCONNECTION HAS BEEN PERFORMED: 9 OTHER COMPLAINTS WITH SIMILAR ISSUE HAVE BEEN IDENTIFIED FOR PORT/CATHETER DISCONNECTION: (B)(4).: "PORT AND CATHETER WERE SEPARATED" - POTENTIAL USE ERROR - NO DEFINITIVE CONCLUSION - UNVERIFIABLE. FINAL PRODUCT: 61.646.55.075, LOT# 120550 (B)(4).: "PORT AND CATHETER WERE SEPARATED" - POTENTIAL USE ERROR - NO DEFINITIVE CONCLUSION - UNVERIFIABLE (NO RETURN PRODUCT). FINAL PRODUCT: 61.646.55.075, LOT# 121580 (B)(4).: "PORT AND CATHETER WERE SEPARATED" - POTENTIAL USE ERROR - NO DEFINITIVE CONCLUSION - UNVERIFIABLE (NO RETURN PRODUCT). FINAL PRODUCT: 61.646.55.075, LOT# 132097 (B)(4).: "CATHETER DROPPED OFF" - POTENTIAL USE ERROR - NO DEFINITIVE CONCLUSION - UNVERIFIABLE (NO RETURN PRODUCT). FINAL PRODUCT 61.636.33.075, LOT# 130971 (B)(4).: "CATHETER DETACHED" - POTENTIAL USE ERROR - NO DEFINITIVE CONCLUSION - UNVERIFIABLE (NO RETURN PRODUCT). FINAL PRODUCT H965451270, LOT# 134811000 (B)(4).: "CATHETER DETACHED" - MATERIAL DEFECT - JUSTIFIED. FINAL PRODUCT H965451110, LOT# 134811000 (B)(4).: "CATHETER SEPARATED DURING EXPLANTATION" - NO DEFINITIVE CONCLUSION - UNVERIFIABLE (NO RETURN PRODUCT) FINAL PRODUCT REF H965451110, LOT# 136713000 (B)(4).: "CATHETER DETACHED FROM PORT" - USE ERROR - JUSTIFIED. FINAL PRODUCT H965451190, LOT# 145023000 (B)(4).: "DISCONNECTION DURING USE" - USE ERROR - UNJUSTIFIED. FINISHED PRODUCT 61.636.09.077-ARM, LOT# 147724000 COMPLAINT RATE: THE PORT CHAMBER IS SOLD ON ALL MARKETS. THE OVERALL COMPLAINT RATE HAS BEEN CALCULATED BASED UPON THE SALE OF ALL PORT CHAMBERS ON ALL MARKETS SINCE 2014 TO JAN 2024: PORT CHAMBER SALES 2014 - JAN 2024: 519'988 OVERALL COMPLAINT RATE 2014-2024 = 10 COMPLAINTS VS. 519'988 UNITS => 0.0019% - 19PPM COMPLAINT RATE VS. VERIFIABLE - JUSTIFIED COMPLAINTS FOR 2014-2024 = 2 VS. 519'998 = 0.00038% = 3.8PPM REVIEW OF RISK ANALYSIS: A) STED-RISK MANAGEMENT PLAN ANALYSIS REPORT_PORTS REV 6 REVIEWED FOR PORT / CATHETER DISCONNECTION', CATHETER MIGRATION': DESIGN RISK: "IMPOSSIBLE TO CONNECT CATHETER TO PIN CONNECTOR" DUE TO CATHETER NOT PROPERLY DESIGNED "IMPOSSIBLE TO CONNECT CLICK ON PORT" DUE TO CLICK NOT PROPERLY DESIGNED "CLICK DOES NOT SECURE CONNECTION" DUE TO WRONG SELECTION OF CLICK TYPE "CATHETER MIGRATION" DUE TO IMPROPER DESIGN OF CONNECTION CONSEQUENCE: CATHETER MIGRATION POTENTIAL OCCURRENCE DUE TO DESIGN = <10PPM (< 0,001%) POTENTIAL OCCURRENCE RATE DUE TO USER = <10PPM (< 0,001%) MANUFACTURING RISK: O "COMPONENT OUT OF SPECIFICATION" DUE TO SUPPLIER CONSEQUENCE: CATHETER MIGRATION DUE TO INCORRECT DIMENSIONS POTENTIAL OCCURRENCE RATE DUE TO MANUFACTURING = <50PPM (0.005%) B) FILE D - VAS001, RISK ANALYSIS, REV 10, REVIEWED FOR PORT / CATHETER DISCONNECTION "CATHETER MIGRATION': DESIGN RISK: "CATHETER DISCONNECTION" DUE WRONG DESIGN OF CONNECTION "CATHETER DISCONNECTION" DUE TO USER ERROR CONSEQUENCE: CATHETER MIGRATION POTENTIAL OCCURRENCE DUE TO DESIGN = 51-500PPM (0.0051 - 0.05%) POTENTIAL OCCURRENCE RATE DUE TO USER = 501-5000PPM (< 0.05 - 0.5%) MANUFACTURING RISK: "CATHETER DETACHED FROM PORT" COMPONENT OUT OF SPECIFICATION DUE TO SUPPLIER CONSEQUENCE: CATHETER MIGRATION DUE TO INCORRECT DIMENSIONS POTENTIAL OCCURRENCE RATE DUE TO MANUFACTURING = 51-500PPM (0.0051 - 0,05%) CONCLUSION: RISK IS IDENTIFIED IN OUR RISK ANALYSIS OCCURRENCE RATE IS BELOW MAX ACCEPTABLE FREQUENCY OF THE RISK ANALYSIS. CONCLUSION: IN ABSENCE OF RETURN PRODUCT TO PERFORM TECHNICAL INVESTIGATION, THE MANUFACTURER WAS LIMITED TO CONDUCT A DOCUMENTARY REVIEW OF THE PRODUCT REFERENCE & BATCH NUMBER: NO DEVIATION WAS RECORDED, WHICH DEMONSTRATES THAT PRODUCT MEETS ITS SPECIFICATIONS. THE DEFECT CANNOT BE CONFIRMED OR REPRODUCED, THEREFORE IT NO DEFINITIVE CONCLUSION AND THE COMPLAINT IS CLASSIFIED AS UNVERIFIABLE.THE RISK FOR PORT/CATHETER IS IDENTIFIED IN OUR RISK ANALYSIS AND OCCURRENCE RATE FOR THE PERIOD OF 2014 TO 2024 IS LOWER THAN ESTABLISHED FREQUENCY OF THE RISK ANALYSIS. THEREFORE, FURTHER ACTION THROUGH CAPA MANAGEMENT AT PFM MEDICAL CPP SA IS NOT REQUIRED. UNABLE TO DETERMINE ROOT CAUSE.
A NURSE REPORTED AN ISSUE WITH A XCELA PT/8.0/SL/F/A, VIA USER FACILITY MEDWATCH. THE FOLLOWING WAS REPORTED: "PATIENT HAD PORT PLACED VIA INTERVENTIONAL RADIOLOGY. HE PRESENTED TO HIS ONCOLOGY OFFICE THE NEXT DAY FOR AN INFUSION. UPON FLUSHING THE PORT IN PREP FOR HIS INFUSION, THE PATIENT COMPLAINED OF PAIN. DUE TO THIS, THE PORT WAS NOT USED. THE NEXT DAY, PATIENT (PT) UNDERWENT A VENOGRAM, WHICH SHOWED THE PORT CATHETER HAD DISLODGED AND MIGRATED TO THE RIGHT ATRIUM. THE PATIENT REQUIRED TRANSFER TO ANOTHER CAMPUS AND CT SURGERY CONSULT. FOUR DAYS AFTER PORT PLACEMENT, HE UNDERWENT SUCCESSFUL LOOP SNARE RETRIEVAL OF THE CATHETER, AND A NEW PORT WAS PLACED FOR HIS ONCOLOGY TREATMENT. IT IS UNKNOWN IF THE PORT/CATHETER WAS FAULTY OR IF IT WASN'T CONNECTED PROPERLY. THE PORT/CATHETER WAS NOT SAVED FOR INSPECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2136251 | XCELA | POWER INJECTABLE PORT | LJT | PFM MEDICAL CPP SA | H965451190 | 153231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Male | Other |