BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 18945126 · Received March 20, 2024

    Report

    Report Number
    2210968-2024-03285
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    June 15, 2023
    Report Date
    March 20, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. 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 SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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 NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: WORLD J PEDIATR SURG 2023; VOL. 6 (E000509), PAGES 1-4. DOI:10.1136/WJPS-2022-000509 PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: DUAL ULTRASOUND-GUIDED TOTALLY IMPLANTABLE VENOUS ACCESS PORTS VIA THE RIGHT INTERNAL JUGULAR VEIN IN PEDIATRIC PATIENTS WITH CANCER: A PRELIMINARY EXPERIENCE IN A SINGLE INSTITUTION. THE AIM OF THIS CASE REPORT IS TO ASSESS THE EFFICACY AND SAFETY OF DUAL ULTRASOUND-GUIDED (DUG) TOTALLY IMPLANTABLE VENOUS ACCESS PORT (TIVAP) IMPLANTATION VIA THE INTERNAL JUGULAR VEIN (IJV) IN PEDIATRIC PATIENTS WITH CANCER. BETWEEN (B)(6) 2019 TO (B)(6) 2020, A TOTAL OF 55 CHILDREN (30 BOYS AND 25 GIRLS) WITH A MEAN AGE OF 2.72 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS UNDERWENT DUAL ULTRASOUND-GUIDED TOTALLY IMPLANTABLE VENOUS ACCESS PORT (DUG-TIVAP) IMPLANTATIONS VIA THE RIGHT INTERNAL JUGULAR VEIN (IJV). DURING SURGERY, AFTER SKIN DISINFECTION AND STERILE DRAPING, THE PERCUTANEOUS ULTRASOUND-GUIDED SELDINGER TECHNIQUE4 WAS PERFORMED. THE RIGHT IJV WAS THEN PUNCTURED UNDER ULTRASOUND. A GUIDE WIRE WAS INSRTED, THEN A CATHETER SHEATH. THE CATHETER WAS THEN CUT TO A SUITABLE LENGTH CONNECTED TO THE PORT, AND THE PORT WAS THEN FIXED USINF TWO ABSORBABLE SUTURES (4¿0 COATED VICRYL; ETHICON, GERMANY). FINALLY, THE SKIN INCISION WAS CLOSED USING CONTINUOUS INTRACUTANEOUS SUTURES (5¿0 COATED VICRYL, ETHICON). REPORTED COMPLICATIONS INCLUDE: 1 PATIENT HAD SKIN INFECTIONS AROUND THE PORT; TREATED WITH ANTIBIOTICS, ANOTHER 1 PATIENT HAD CATHETER-RELATED INFECTION; ALSO TREATED WITH ANTIBIOTICS, AND 1 PATIENT HAD FIBRIN SHEATH FORMATION; MANAGED WITH THROMBOLYSIS. CONCLUSIONS: DUG-TIVAP IMPLANTATION IS A TECHNIQUE WITH A HIGH SUCCESS RATE AND A LOW COMPLICATION RATE; THEREFORE, IT PROVIDES AN ALTERNATIVE FOR CHILDREN WITH CANCER. FURTHER RANDOMIZED CONTROLLED STUDIES ARE NEEDED TO CONFIRM THE EFFICACY AND SAFETY OF DUG-TIVAP VIA THE RIGHT IJV IN CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892263 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention