BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVOX VEGA PUNCTURE SET

    MDR report key: 20830726 · Received December 3, 2024

    Report

    Report Number
    8032044-2024-00007
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    November 7, 2024
    Report Date
    December 3, 2024
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    EWL
    PMA / PMN Number
    K131947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION THIS COMPLAINT IS ASSESSED TO NOT BE PRODUCT RELATED. IT IS ASSESSED AS A USER ERROR DURING SURGERY COMBINED WITH INADEQUATE POST OP PROCEDURE. ACTION, EDUCATION: ONGOING EDUCATION AND SUPPORT IS PLANNED FOR 2025 FROM THE NKI SURGEONS, IN THE FORM OF TEAMS CALLS TO TROUBLESHOOT AND A SURGEON WILL VISIT FOR FURTHER SURGICAL EDUCATION. INVESTIGATION THIS IS A THEORETICAL INVESTIGATION; SAMPLE WAS NOT AVAILABLE. THE PROSTHESIS IS CURRENTLY USED BY THE PATIENT. CLINICAL EXPERT AVAILABLE FOR CONSULTATION: (B)(6). FOLLOW-UP QUESTIONS: 1. HOW WAS THE PHARYNX PROTECTED DURING THE SECONDARY PUNCTURE? PLEASE DESCRIBE EACH STEP OF THE SURGICAL PROCEDURE. ANSWER: ATOS EMPLOYEES WERE NOT IN THE OPERATING ROOM. ACCORDING TO THE SURGEONS, THEY FOLLOWED STANDARD PUNCTURE PROCEDURES. A) ADJUSTED THE POSITION OF THE PATIENT'S HEAD AND NECK TO FACILITATE THE INSERTION OF THE RIGID ESOPHAGOSCOPE. B) THEY CAREFULLY INSERTED A RIGID ESOPHAGOSCOPE WITH A LIGHT SOURCE, FROM THE MIDDLE OF WHICH THEY OBSERVED THE SITUATION OF THE ESOPHAGUS. THE LIGHT FROM THE ESOPHAGOSCOPE CAN PASS THROUGH THE SKIN, WHICH HELPS TO VERIFY THE POSITION OF THE ESOPHAGOSCOPE. C) WHEN THE ESOPHAGOSCOPE REACHED THE APPROPRIATE PUNCTURE POSITION, THEY INSERTED THE PUNCTURE NEEDLE. D) THEY INSERTED THE GUIDE WIRE UNTIL IT EXTENDED THE END OF THE ESOPHAGOSCOPE. E) THEY THEN REMOVED THE PUNCTURE NEEDLE. F) THEY REMOVED THE ESOPHAGOSCOPE. G) THEY CONNECTED THE GUIDE WIRE AND THE DILATOR. THEY PULLED THE GUIDE WIRE AND INSERTED THE VOICE PROSTHESIS. 2. CHEST PAIN AFTER A PROCEDURE LIKE THIS WOULD HAVE BEEN ONE SITUATION THAT REQUIRE IMMEDIATE FOLLOW-UP. WAS THE PATIENT ADVISED TO CONTACT A HEALTH-CARE PROFESSIONAL IF COMPLICATIONS OCCURRED? WHICH COMPLICATIONS WERE MENTIONED? ANSWER: YES, THE PATIENT HAD CONTACTED THE DOCTOR ONLINE ABOUT THE PAIN. DOCTOR ADVISED THE PATIENT TO TAKE ENOUGH REST, GO TO HOSPITAL AND TAKE MEDICAL EXAMINATION IF NECESSARY. BUT THE PATIENT DID NOT PAY TOO MUCH ATTENTION TO IT BECAUSE: A) THE PATIENT LIVES IN ANOTHER PROVINCE. B) THERE WAS NOTHING WRONG OR ABNORMALITY IN THE APPEARANCE OF STOMA AND THE PUNCTURE SITE. C) THE PATIENT COULD SPEAK. D) THE PATIENT WANTED TO WAIT FOR SEVERAL DAYS TO SEE IF THE PAIN WOULD DISAPPEAR. 3. ON WHAT GROUNDS WAS THE CT SCAN DECIDED? ANSWER: THE PATIENT WAITED FOR A WEEK AND THE PAIN DID NOT RELIEVE. THEN THE PATIENT DECIDED TO GO TO THE LOCAL HOSPITAL TO HAVE A CT SCAN. 4. IS THE ACTUAL PROSTHESIS WORKING AS INTENDED? ANSWER: YES, THE PATIENT CAN SPEAK AND THE VOICE PROSTHESIS WORKS WELL. 5. HAS THE PATIENT NOW RECOVERED AS COULD BE EXPECTED? ANSWER: YES, THE PATIENT IS NOW RECOVERING. 6. IS THE PUNCTURE FULLY HEALED? ANSWER: YES. THERE IS NOTHING WRONG OR ABNORMALITY ON THE PUNCTURE SITE. 7. WHAT MEDICATIONS WERE GIVEN TO THE PATIENT DAYS AFTER THE SECONDARY PUNCTURE (FIRST SURGERY)? ANSWER: CEPHALOSPORIN WAS GIVEN FOR 3 DAYS. NASAL FEEDING TUBE FOR TEN DAYS. ROOT CAUSE: PROBABLE USER ERROR DURING SURGERY IN COMBINATION WITH INADEQUATE POST OP PROCEDURE. DISCUSSION: THE PROSTHESIS IS DELIVERED STERILE TO THE CUSTOMER. LOT DOCUMENTATIONS ARE REVIEWED AND FOUND TO BE IN ORDER. EXCERPT FROM INSTRUCTION FOR USE (REF 10881) PROVOX VEGA PUNCTURE SET: 2.4 IMPORTANT PATIENT INFORMATION ENSURE THAT THE PATIENT UNDERSTANDS TO CONTACT CLINICIAN IF: -THERE ARE ANY SIGNS OF INFLAMMATION OR TISSUE CHANGE AT OR NEAR THE PUNCTURE TRACT. -PERSISTENT PAIN OR DISCOMFORT IN THE REGION OF THE VEGA VOICE PROSTHESIS. NO NC¿S/CAPAS FOUND RELEVANT TO THIS COMPLAINT. COMPLAINTS WITH THE SAME LOT NUMBER NOT FOUND. NO UNFAVORABLE TRENDS IN COMPLAINT OR VIGILANCE DATA.

    Description of Event or Problem · 0

    THIS THE 14TH VP PATIENT IN (B)(6) HOSPITAL. THE SURGERY WAS A SECONDARY PUNCTURE, WHICH MEANS THAT THE PATIENT HAD ALREADY BEEN LARYNGECTOMIZED. IN A SECONDARY PUNCTURE SURGERY, A PUNCTURE IS MADE IN THE WALL BETWEEN THE ESOPHAGUS AND TRACHEA TO FACILITATE THE PLACEMENT OF A VOICE PROSTHESIS. THE PATIENT FELT CONTINUOUS CHEST AND BACK PAIN ONE DAY AFTER THE PUNCTURE, BUT THE PATIENT DID NOT PAY TOO MUCH ATTENTION TO IT BECAUSE THE PATIENT COULD SPEAK AND THERE WERE NO OTHER ABNORMALITIES ON THE APPEARANCE. NASAL FEEDING TUBE WAS GIVEN FOR TEN DAYS. 14 DAYS AFTER THE PUNCTURE, THE PATIENT HAD A CT SCAN. RESULT SHOWED THAT THE PATIENT HAD A SEVER DEEP NECK INFECTION IN THE LEVEL OF C6-C7. DOCTOR CLAIMED THAT THE PATIENT WAS IN CRITICAL CONDITION AND NEEDED EMERGENCY SURGERY. THE EMERGENCY SURGERY WAS CONDUCTED TOGETHER WITH ORTHOPEDIST, BECAUSE THE INFECTION WAS SO SERIOUS THAT THE DOCTOR HAD TO REMOVE A PART OF THE PATIENT'S CERVICAL VERTEBRAE AND REPLACE WITH A SMALL PIECE OF ILIUM. THE PATIENT WAS THEN HOSPITALIZED WITH A VOICE PROSTHESIS IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291243 PROVOX VEGA PUNCTURE SET TRACHEOESOPHAGEAL SPEECH VALVE, INDWELLING EWL ATOS MEDICAL AB 2308091_L814801720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| S