TJL II CONTRAST BASIC PUR

Description of Event or Problem

REPORTED DEFECT: SUSPECTED EXTRAVASATION/INFILTRATION TO CHEST AREA/ WALL. PATIENT HAD A CHEST PORT INSERTED TO LEFT CHEST WALL VIA LIJ VEIN UNDER FLUOROSCOPY GUIDANCE ON (B)(6) 2023. UNEVENTFUL PROCEDURE. PATIENT ATTENDED FOR IV TREATMENT (EC - EPIRRUBICIN AND CYCLOPHOSPHAMIDE) ON (B)(6) 2023. TREATMENT ADMINISTERED WITHOUT ANYTHING TO REPORT ON NURSING DOCUMENTATION. ON (B)(6) 2023, PATIENT CALLED HOTLINE C/O SWELLING AND PAIN/ DISCOMFORT IN CHEST AREA WHERE PORT WAS IMPLANTED. UPON REVIEW THAT DAY, SUSPECTED EXTRAVASATION/ INFILTRATION TO CHEST AREA/ WALL. THIS HAS BEEN MONITORED AND FOLLOWED UP. INTERNALLY INVESTIGATED BY THE ORGANISATION. PORT REMOVED INTACT AND UNEVENTFULLY ON (B)(6) 2024. BEFORE REMOVAL, CT CONTRAST ADMINISTERED THROUGH PORT TO CHECK FOR OBVIOUS LEAKAGE UNDER FLOUROSCOPY. NO OBVIOUS LEAKAGE.

Additional Manufacturer Narrative

RESULT OF INVESTIGATION: PRELIMINARY INVESTIGATION REVIEW OF DEVICE HISTORY RECORDS: - FINISHED GOODS PRODUCT: 61.636.83.077-V, LOT# 153327. BATCH RECORDS IS COMPLETE. NO ISSUE WAS RECORDED DURING THE MANUFACTURING OF THIS LOT 153327. THE FINISHED GOODS PRODUCT MEETS ITS SPECIFICATION PER INSPECTIONS RECORDS. RETURN PRODUCT VERIFICATION · THE REPORTED PORT HAS BEEN RETURNED IN A CLOSED CUP AND CLOSED BAG. IT IS A HIGH PRESSURE PORT CHAMBER ON WHICH THE ENTIRE IMPLANTED CATHETER IS STILL CONNECTED TO IT (CATHETER LENGTH = 24CM) VISUAL INSPECTION : - CONFIRMED PRODUCT LOT# 153327. - DID NOT IDENTIFY ANY TRACE OF PUNCTURE OUTSIDE THE SEPTUM, NOR VISIBLE SIGNS OF PARTICULAR DAMAGE. - DID NOT IDENTIFY ANY VISUAL SIGNS OF MISS ASSEMBLY OF THE CLICK CONNECTOR THE PORT WAS THEN TESTED FOR FLOW, TO VERIFY / CONFIRM THERE IS NO PORT CLOGGING. THE VERIFICATION WAS PERFORMED USING A HUBER NEEDLE FORM OUR INTERNAL STOCK AND A MANUAL PRESSURE SYRINGE. THE TEST CONFIRMS THERE IS NO PORT BLOCKAGE. THIS TEST WAS PERFORMED UNDER VIDEO AND FILE IS AVAILABLE IN THE COMPLAINT FOLDER (B)(4). EXTRACT: THE PORT WAS THEN FILLED WITH TAPE WATER AND THE CATHETER CLAMPED AT ITS DISTAL END. THE ENTIRE SYSTEM HAS BEEN PUT UNDER PRESSURE WITH A MANUAL PRESSURE SYRINGE. THE PORT WAS TESTED WITH NO VISIBLE LEAK UP TO 19 BARS (275PSI). IT WAS A VOLUNTARY DECISION NOT PRESSURIZING OVER 19 BARS, IN ORDER NOT TO DAMAGE THE PORT. THIS TEST WAS PERFORMED UNDER VIDEO AND FILE IS AVAILABLE IN THE COMPLAINT FOLDER (B)(4). CONCLUSION: THE TEST UNDER HIGH PRESSURE WITH TAPE WATER CONFIRMED THE RETURNED MATERIAL IS NOT LEAKING AND THE CONNECTION OF THE CATHETER TO THE PORT WAS PROPERLY DONE DURING ORIGINAL IMPLANTATION. THE REPORTED DEFECT "LEAK" COULD NOT BE REPRODUCED. NO MICRO LESIONS LEADING TO LEAK HAVE BEEN OBSERVED. IN CONSEQUENCE, MOST PROBABLE CAUSE OF THE EVENT IS A MISS PUNCTURE ON (B)(6) 2023 WHICH THEN LEAD TO THE PATIENT CALL ON (B)(6) 2023 FOR SWELLING AND PAIN IN CHEST AREA. THERE MUST HAVE BEEN A SPECIFIC EVENT, INDEPENDENTLY OF THE IMPLANT FUNCTIONALITY, AS THE CT CONTRAST PERFORMED PRIOR TO DEVICE EXPLANTATION DID NOT REVEAL ANY LEAK OF THE MEDICAL DEVICE. THIS COMPLAINT IS CLASSIFIED AS NO DEFINITIVE CONCLUSION' AND UNJUSTIFIED'. REVIEW OF SIMILAR COMPLAINTS: THE COMPLAINT SEARCH WAS FIRST SORTED ON 'VAS' PRODUCT AND THEN FILTERED IN COLUMN CONCLUSION FOR 'MIS-PUNCTURE': (B)(4) COMPLAINTS WERE IDENTIFIED: COMPLAINT RATE: (B)(6) 2014 - (B)(6)2024: ALL MARKETS: (B)(4) PORTS. COMPLAINTS' RATE (B)(4) OCCURRENCES VS. (B)(4) UNITS = (B)(4) 21.8PPM. REVIEW OF RISK ANALYSIS: FILE D - VAS001 REV 10: -"LEAK" DUE TO USER RISKS "DEVICE IMPLANTATION", "USE ERROR" (INCORRECT CONNECTION OF THE CATHETER, CATHETER DAMAGE, MISPUNCTURE, USE OF CORING NEEDLE) CONSEQUENCE: NECROSIS, INFLAMMATION, TISSUE DAMAGES, PATIENT DISCOMFORT DEFINED POTENTIAL OCCURRENCE RATE: <50PPM = (B)(4) COMPLAINTS' RATE (B)(4) OCCURRENCES VS. (B)(4) UNITS = (B)(4) 21.8PPM IS BELOW THE THRESHOLD. RISK IS IDENTIFIED IN OUR RISKS ANALYSIS & OCCURRENCE'S RATE BELOW DEFINED ACCEPTABLE FREQUENCY OF THE RISK ANALYSIS. FILE STED RISK MANAGEMENT ANALYSIS REPORT_PORT, REV 7 "EXTRAVASATION / LEAK" DUE TO USER ERROR (PALPATION) CONSEQUENCE: NECROSIS, INFLAMMATION, TISSUE DAMAGES, PATIENT DISCOMFORT DEFINED POTENTIAL OCCURRENCE RATE: <10PPM = (B)(4). OVERALL COMPLAINTS' RATE (B)(4) OCCURRENCES VS. (B)(4) UNITS = (B)(4) 21.8PPM IS ABOVE THE THRESHOLD. IT IS IDENTIFIED THAT [?]EXTRAVASATION' OR LEAK' ARE MAINLY DUE TO USE ERROR FOR WHICH THE EXPECTED OCCURRENCE RATE WAS ANTICIPATED TO BE VERY LOW AS RISKS OF MIS-PUNCTURE HAVE BEEN REDUCED PER DESIGN AND PER IFU (SEE EXTRACT BELOW) AS LOW AS POSSIBLE. BASED UPON THE ABOVE REVIEW IT IS CONCLUDED THAT THE RISK MANAGEMENT DOCUMENT STED RISK MANAGEMENT ANALYSIS REPORT_PORT' SHOULD BE REVISED ACCORDINGLY. REVIEW OF NC AND CAPA: NO INTERNAL NC OR CAPA WAS IDENTIFIED. CONCLUSION: THE MANUFACTURER CONDUCTED A DOCUMENTARY AND RETURNED PRODUCT INVESTIGATION INTO THE REPORTED PROBLEM WITH COMPLETE, DHR AND TESTING DATA REVIEW AND PRODUCT REVIEW: - THIS DOCUMENT REVIEW CONCLUDED THAT THE PRODUCT (PROCEDURE PACK) MEETS ITS SPECIFICATION. - THE PRODUCT REVIEW PERFORMED BY PFM CPP COULD NOT REPRODUCE A DEVICE LEAK NOR DRAW A FORMAL CONCLUSION.

Description of Event or Problem

REPORTED DEFECT: SUSPECTED EXTRAVASATION/INFILTRATION TO CHEST AREA/ WALL. PATIENT HAD A CHEST PORT INSERTED TO LEFT CHEST WALL VIA LIJ VEIN UNDER FLUOROSCOPY GUIDANCE ON (B)(6) 2023. UNEVENTFUL PROCEDURE. PATIENT ATTENDED FOR IV TREATMENT (EC - EPIRRUBICIN AND CYCLOPHOSPHAMIDE) ON (B)(6) 2023. TREATMENT ADMINISTERED WITHOUT ANYTHING TO REPORT ON NURSING DOCUMENTATION. ON (B)(6) 2023, PATIENT CALLED HOTLINE C/O SWELLING AND PAIN/ DISCOMFORT IN CHEST AREA WHERE PORT WAS IMPLANTED. UPON REVIEW THAT DAY, SUSPECTED EXTRAVASATION/ INFILTRATION TO CHEST AREA/ WALL. THIS HAS BEEN MONITORED AND FOLLOWED UP. INTERNALLY INVESTIGATED BY THE ORGANISATION. PORT REMOVED INTACT AND UNEVENTFULLY ON (B)(6) 2024. BEFORE REMOVAL, CT CONTRAST ADMINISTERED THROUGH PORT TO CHECK FOR OBVIOUS LEAKAGE UNDER FLOUROSCOPY. NO OBVIOUS LEAKAGE.