SPRAY CATHETER

Additional Manufacturer Narrative

THIS IS THE FIRST REPORT. ANOTHER MFR REPORT #: 3004837686-2025-00003. 1.INCIDENT DESCRIPTION. ADAPTER APPLIED TO PURASTAT GEL SYRINGE AND SPRAY CATHETER AND PURASTAT GEL INJECTED INTO CATHETER SYRINGE THEN DISCONNECTED AND FILLED WITH AIR AS IFU INSTRUCTS. AFTER SYRINGE APPLIED BACK ONTO SPRAY CATHETER TO DELIVER THE GEL FROM THE CATHETER IT WAS FOUND TO HAVE NO GEL EXPELLING CATHETER. UPON FURTHER EXAMINATION IT APPEARED THAT BLUE CONNECTION PORT ON SPRAY CATHETER WAS CRACKED WHICH KEPT THE PRODUCT FROM DISPENSING. 2.EXTERNAL INVESTIGATION ON (B)(6) 2025, MICRO-TECH HAS COMMUNICATED WITH CUSTOMER TO DETERMINE IF THERE ARE ANY OTHER CLINICAL USAGE INFORMATION. AS OF (B)(6) 2025, NO RESPONSE HAS BEEN RECEIVED. MEANWHILE, MICRO-TECH WILL CONDUCT AN INTERNAL INVESTIGATION AND ANALYSIS. 3.INTERNAL INVESTIGATIONS: ACCORDING TO THE COMPLAINT INFORMATION, IT HAS BEEN CONFIRMED THAT SPRAY CATHETER INFUSION HANDLE HAS BROKEN. IN RESPONSE TO THIS PHENOMENON, WE HAVE INVESTIGATED AND ANALYZED IT FROM THE ASPECTS OF STRUCTURAL DESIGN, RAW MATERIALS, PRODUCTION PROCESS, TECHNICAL STANDARDS, AND USAGE METHODS AS FOLLOWS: 3.1STRUCTURAL DESIGN: THIS SPRAY CATHETER IS COMPOSED OF A NOZZLE, A SCREW, A CATHETER, A PROTECTIVE SLEEVE, AND A HANDLE (LUER JOINT). ANALYSIS: THE WORKING PRINCIPLE OF SPRAY CATHETER IS "THE PRODUCT IS USED FOR LAVAGE, SPRAYING OF A STAIN, OR SOLUTION, IN THE GASTROINTESTINAL TRACT BY PASSING THROUGH THE WORKING CHANNEL OF A FLEXIBLE ENDOSCOPE. ACCODRING TO THE COMPLAINT STATISTICS. THIS TYPE OF COMPLAINT OF OCCURRENCE IS VERY LOW, INDICATED THAT THE STRUCTURAL DESIGN HAS STABILITY AND RELIABILITY. THEREFORE, IT IS JUDGED THAT THE STRUCTURAL DESIGN OF SPRAY CATHETER CAN MEET CLINICAL REQUIREMENTS. 3.2RAW MATERIAL: THIS SPRAY CATHETER CONSISTS OF NOZZLE, SCREW, CATHETER, PROTECTIVE SLEEVE AND HANDLE (LUER JOINT). WE HAVE CHECKED THE BATCH OF RAW MATERIALS AND FOUND THAT THE MATERIAL, APPEARANCE, AND DIMENSIONS HAVE ALL PASSED THE INSPECTION AND BEEN PUT INTO STORAGE. 3.3PRODUCTION PROCESS: WE HAVE INVESTIGATED THE RELEVANT PROCESS STEPS DURING THE PRODUCTION PROCESS AND COMBINED THEM WITH PROCESS RISK ANALYSIS: HANDLE ASSEMBLY: AFTER THE HANDLE ASSEMBLY, IT IS NECESSARY TO SELF-CHECK THE SURFACE OF THE HANDLE SMOOTH, CLEAN, NO BURRS AND OTHER BAD APPEARANCE. IF THE CONNECTION IS LEAKAGE, IT CAN BE FOUND IN TIME DURING SELF-INSPECTION; AIR TIGHTNESS TEST: CONNECT THE HANDLE TAIL TO THE LUER CONNECTOR OF THE AIR VALVE, PLACE THE CONNECTION BETWEEN THE HANDLE AND THE CATHETER BELOW THE WATER SURFACE, CONNECT 50KPA OF AIR PRESSURE, KEEP 5S, AND OBSERVE WHETHER THERE ARE BUBBLES AT THE CONNECTION BETWEEN THE HANDLE AND THE CATHETER. IF THE JOINT IS LEAKAGE, THE OPERATOR CAN FIND IT IN TIME WHEN CONNECTING WITH THE LUER JOINT OF THE VALVE. SPRAY ALCOHOL: USE A 20ML SYRINGE TO INJECT ALCOHOL INTOSPRAY CATHETER FOR SPRAYING. ALCOHOL SHOULD BE NORMALLY EJECTED FROM THE DISTAL END OF SPRAY CATHETER, AND THE EJECTED ALCOHOL SHOULD BE IN THE SHAPE OF MIST. IF THERE IS LEAKAGE DURING THE PROCESS OF SPRAYING ALCOHOL, AND THE OPERATOR CAN ALSO DETECT IT IN A TIMELY MANNER WHEN CONNECTING TO THE SYRINGE. PROCESS INSPECTION: VISUALLY, THE DISTANCE IS 30-45CM, THE HANDLE SURFACE IS SMOOTH, CLEAN, NO BURRS AND OTHER BAD APPEARANCE. SUCH AS SPRAY CATHETER JOINT CRACK IS BAD, IN THE INSPECTION, CAN BE FOUND IN TIME. ANALYSIS: WE HAVE INVESTIGATED THE RELEVANT PROCESSES THAT MAY HAVE CAUSED THE LEAKAGE OF SPRAY CATHETER, BUT HAVE NOT FOUND ANY PROCESSES THAT CAUSED THE LEAKAGE. 3.4TECHNICAL STANDARD 3.4.1 WATER SHOULD BE INJECTED FROM THE NEAR END OF THE SPRAY CATHETER, AND THE WATER SHOULD BE DISCHARGED SMOOTHLY FROM THE FAR END. 3.4.2 NO DISCOUNTING OCCURS IN THE SPRAY CATHETER DURING THE TEST LENGTH. 3.4.3 THE CONNECTION BETWEEN THE SPRAY CATHETER CONDUIT AND THE LIQUID INJECTION HANDLE SHOULD BE>=10N. 3.4.4 THE NOZZLE AND SPIROCHAETA SHOULD NOT BE SEPARATED FROM THE OUTER TUBE DURING THE SPRAYING PROCESS. 3.4.5 THE CONNECTING PARTS OF THE PRODUCT SHALL NOT LEAK UNDER THE CONDITION OF LIQUID INJECTION. ANALYSIS: THE CUSTOMER COMPLAINT OF THE SPRAY CATHETER DESCRIBED THAT "CATHETER HAD BREAKING ISSUE. "THERE SHALL BE NO LEAKAGE IN THE CONNECTING PARTS OF THE PRODUCT UNDER THE CONDITION OF LIQUID INJECTION." IN THE EARLY VALIDATION STAGE, WE HAVE ALSO PASSED A LARGE NUMBER OF CLINICAL DATA TO PROVE THAT THE DESIGN OF THE SPRAY CATHETER CAN OBJECTIVELY MEET THE PRODUCT PERFORMANCE REQUIREMENTS, AND THERE IS NO PROBLEM IN THE SETTING OF TECHNICAL STANDARDS. 3.5USAGE METHODS 3.5.1. UNDER ENDOSCOPIC VIEW, IDENTIFY THE AREA OF INTEREST. 3.5.2. INSERT THE SPRAY CATHETER INTO THE WORKING CHANNEL USING SHORT MOVEMENTS UNTIL THE DISTAL TIP IS VISIBLE IN THE ENDOSCOPIC VIEW. 3.5.3. CONNECT THE HANDLE OF THE SPRAY CATHETER TO A SYRINGE, AND THEN CARRY OUT LAVAGE, SPRAYING OF A STAIN, MEDICAL SOLUTION OR CONTRAST MEDIUM, ETC. UNDER DIRECT ENDOSCOPIC VISUALIZATION. 3.5.4. AFTER APPLICATION, WITHDRAW THE SPRAY CATHETER FROM THE CHANNEL EXERCISING CARE WHEN THE DISTAL TIP EXITS THE ENDOSCOPE BIOPSY VALVE. CAUTION: RAPID WITHDRAWAL MAY LEAD TO SPLASHING OF THE INJECTION MEDIA. CAUTION SHOULD BE USED AND APPROPRIATE PERSONAL PROTECTION GUIDELINES FOLLOWED. ANALYSIS: THE FEEDBACK ON THE ENDOSCOPIC SPRAY CATHETER THIS TIME IS DESCRIBED AS A BROKEN HANDLE ISSUE. THE INSTRUCTIONS EXPLAIN THE USAGE: CONNECT THE HANDLE OF THE SPRAY CATHETER TO A SYRINGE, AND THEN CARRY OUT LAVAGE, SPRAYING OF A STAIN, MEDICAL SOLUTION OR CONTRAST MEDIUM, ETC. UNDER DIRECT ENDOSCOPIC VISUALIZATION." THE DESCRIPTION IS CLEAR AND CLEAR WITHOUT AMBIGUITY. THEREFORE, WE CONFIRM THAT THE UNCLEAR DESCRIPTION OF THE USE METHOD WILL NOT LEAD TO IMPROPER OPERATION OF THE USER AND CAUSE THIS ADVERSE EVENT. 3.6STORAGE AND TRANSPORTATION FOR THE STORAGE AND TRANSPORTATION OF SPRAY CATHETER PRODUCTS, WE HAVE CLEAR REQUIREMENTS: 3.6.1 THE PRODUCT SHOULD BE STORED IN A COOL DRVCLEANWEL-VENTILATED ENVIRONMENT 3.6.2 DO NOT EXPOSE THE PACKAGE TO ORGANIC SOLVENT, IONIZING RADIATION OR ULTRAVIOLET RADIATION. ANALYSIS: THE SPRAY CATHETER IN THE DESIGN AND DEVELOPMENT STAGE OF THE PERFECT VALIDITY CERTIFICATE, AT THE SAME TIME, SPRAY CATHETER HAS BEEN CONFIRMED FOR TRANSPORTATION, TO DETERMINE THE PACKAGING CAN MEET THE PROTECTION NEEDS OF THE PRODUCT, MORE DETAILED STORAGE AND TRANSPORTATION CONDITIONS ARE ALSO DETAILED IN THE MANUAL. THEREFORE, WE DETERMINED THAT THE MODE OF STORAGE AND TRANSPORTATION WOULD NOT CAUSE THIS ADVERSE EVENT. CONCLUSION: SPRAY CATHETER BROKE. AFTER ANALYZING AND INVESTIGATING THE STRUCTURAL DESIGN, RAW MATERIALS, PRODUCTION PROCESS, TECHNICAL STANDARDS, USAGE METHODS, AND STORAGE AND TRANSPORTATION OF THE SPRAY CATHETER, THE ROOT CAUSE OF THIS INCIDENT WAS NOT FOUND, WE WILL CONTINUE TO MONITOR THIS ISSUE TO ENSURE PATIENT SAFETY.

Description of Event or Problem

ON 12/30/2024, MICRO-TECH RECEIVED 1 INCIDENT REPORT REGARDING SPRAY CATHETER FROM FDA. UF REPORT#: (B)(4). IT WAS REPORTED THAT -D MATRIX PURASTAT SPRAY CATHETER LOT# M230925311 REF#(B)(4) ADAPTER APPLIED TO PURASTAT GEL SYRINGE AND SPRAY CATHETER AND PURASTAT GEL INJECTED INTO CATHETER SYRINGE THEN DISCONNECTED AND FILLED WITH AIR AS IFU INSTRUCTS. AFTER SYRINGE APPLIED BACK ONTO SPRAY CATHETER TO DELIVER THE GEL FROM THE CATHETER IT WAS FOUND TO HAVE NO GEL EXPELLING CATHETER. UPON FURTHER EXAMINATION IT APPEARED THAT BLUE CONNECTION PORT ON SPRAY CATHETER WAS CRACKED WHICH KEPT THE PRODUCT FROM DISPENSING.

Additional Manufacturer Narrative

THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCTS RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. HOWEVER, THE INCIDENT INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE INCIDENT INVESTIGATION.