BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SUCTION COAGULATOR

    MDR report key: 20912695 · Received December 12, 2024

    Report

    Report Number
    1721194-2024-00098
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    May 23, 2024
    Report Date
    December 12, 2024
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559105153
    PMA / PMN Number
    K072559
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/12/2024. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: DIRECT TUMORAL PUNCTURE EMBOLIZATION OF ONYX BEFORE ENDOSCOPIC ENDONASAL RESECTION OF A MASSIVE JUVENILE ANGIOFIBROMA FOR A PATIENT WITH VON WILLEBRAND DISEASE ¿ A CASE REPORT AND REVIEW OF LITERATURE AUTHOR(S): LAURA-ELISABETH GOSSELIN, PIERRE-OLIVIER CHAMPAGNE, PASCALE LAVOIE, SYLVIE NADEAU. CITATION: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS 120 (2024) 109784. THE AIM OF THIS STUDY IS TO DEMONSTRATE THE SAFETY AND THE USEFULNESS OF THIS EMBOLIZATION TECHNIQUE ON A PEDIATRIC CASE OF JUVENILE ANGIOFIBROMA AND TO COMPARE OUR RESULTS TO PREVIOUSLY REPORTED CASES. THIS IS A CASE OF A 12-YEAR-OLD PATIENT SUFFERING FROM VON WILLEBRAND DISEASE PRESENTED WITH VOLUMINOUS JUVENILE ANGIOFIBROMA WITH INTRACRANIAL EXTENSION. INTERNAL CAROTID ARTERY BRANCHES PARTIALLY VASCULARIZED THE TUMOR. THE PATIENT UNDERWENT SURGICAL INTERVENTION WITH ENDONASAL ENDOSCOPIC APPROACH. SURGICAL RESECTION OF THE ANTERIOR TUMORAL SECTION AND A PARTIAL DEBULKING OF THE RIGHT ORBIT WAS ACHIEVED WITH MEGADYNE¿ SUCCION COAGULATORS (ETHICON©). HOWEVER, AFTER A PARTIAL RESECTION OF THE NASOPHARYNX PORTION, AN IMPORTANT TUMORAL BLEEDING COMPELLED SURGEONS TO STOP THE SURGERY. TOTAL BLOOD LOSS WAS 1 L. THE PATIENT STAYED HEMODYNAMICALLY STABLE BUT RECEIVED ONE TRANSFUSION POSTOPERATIVELY. A SECOND SURGICAL INTERVENTION TOOK PLACE A MONTH LATER. VIA AN ENDONASAL ENDOSCOPIC APPROACH, SURGEONS COAGULATED THE TUMOR CAPSULE WITH A COMPETITOR AQUAMANTYS ¿ BIPOLAR SYSTEM (MANUFACTURER: MEDTRONIC). SMALL TUMORAL SECTIONS WERE RESECTED BUT A SIGNIFICANT BLEEDING PROMPTLY OCCURRED, COMING FROM THE RIGHT POSTERIOR ETHMOIDAL TUMORAL SECTION. TOTAL BLOOD LOSS WAS 1.6 L. THE PATIENT REMAINED HEMODYNAMICALLY STABLE BUT WAS GIVEN 2 TRANSFUSIONS DURING SURGERY. A DIFFERENT PREOPERATIVE EMBOLIZATION TECHNIQUE WAS THEN PERFORMED, USING AN INTRA-TUMORAL DIRECT PUNCTURE OF A COMPETITOR ONYX® TO DIRECTLY OCCLUDE TUMORAL FEEDING VESSELS, INCLUDING INTERNAL CAROTID ARTERY BRANCHES. NO COMPLICATION OCCURRED. THE PROCEDURE DEVASCULARIZED 90% OF THE TUMOR. 3 DAYS LATER, THE PATIENT UNDERWENT HIS THIRD SURGERY. THE NASO-ETHMOIDAL SECTION WAS RESECTED AND EXTRUDED BY THE PATIENT'S MOUTH. RESIDUAL SKULL BASE TUMOR WAS THEN DISSECTED. TO PREVENT THE ONSET OF CSF LEAK, A NASOSEPTAL FLAP WAS USED TO SEAL THE DEFECT. SURGICEL® (ETHICON) AND A COMPETITOR NASOPORE® (MANUFACTURER: STRYKER) WERE USED TO TEMPORARILY OBLITERATE THE NASAL CAVITY AND TO PROTECT RECONSTRUCTION. THE FOLLOW-UP TO THIS DATE REVEALED NO LATE COMPLICATION AND NO RESIDUAL SYMPTOMS. REPORTED COMPLICATIONS INCLUDED IMPORTANT TUMORAL BLEEDING WHICH COMPELLED SURGEONS TO STOP THE SURGERY (N=1). IN CONCLUSION, DIRECT INTRATUMORAL ONYX EMBOLIZATION ALLOWED COMPLETE RESECTION OF A MASSIVE JUVENILE ANGIOFIBROMA, FOR A PATIENT WITH VON WILLEBRAND DISEASE. OUR DATA SUGGEST THAT THIS TECHNIQUE IS SAFE AND MAY BE INSTRUMENTAL FOR A JUVENILE ANGIOFIBROMA¿S RESECTION, EVEN IF LITTLE VASCULARIZATION COMES FROM INTERNAL CAROTID ARTERY BRANCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147051 UNK_SUCTION COAGULATOR UNK_SUCTION COAGULATOR GEI MEGADYNE MEDICAL PRODUCTS, INC. 10614559105153

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention