BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9984398 · Received April 21, 2020

    Report

    Report Number
    2210968-2020-03329
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Report Date
    March 26, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (:VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE ( HEMATOMA , RE-BLEEDING)? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE COMPLAINT REFERENCE NUMBERS. PATIENT DEMOGRAPHICS THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: CARDIOL RES. 2019; 10(5): 303-308. DOI: HTTPS://DOI.ORG/10.14740/CR931. (B)(4).

    Description of Event or Problem · 1

    TITLE: EFFICACY AND SAFETY OF SUBCUTANEOUS FELLOW¿S STITCH USING ¿FISHERMAN¿S KNOT¿ TECHNIQUE TO ACHIEVE LARGE CALIBER (> 10 FRENCH) VENOUS HEMOSTASIS AMONG PATIENTS UNDERGOING INTERVENTION INVOLVING VENOUS ACCESS, VARIOUS TECHNIQUES HAVE BEEN IMPLEMENTED TO ACHIEVE HEMOSTASIS IN ORDER TO REDUCE LOCAL ACCESS SITE COMPLICATIONS, TO DECREASE LENGTH OF STAY AND TO FACILITATE EARLY AMBULATION. THE AUTHORS AIMED TO ASSESS THE EFFICACY AND SAFETY OF FELLOW¿S STITCH USING ¿FISHERMAN¿S KNOT¿ (FIGURE OF Z (FOZ)) TECHNIQUE WHEN COMPARED WITH CONVENTIONAL MANUAL COMPRESSION FOR IMMEDIATE CLOSURE OF LARGE VENOUS SHEATH. BETWEEN NOVEMBER 2012 AND MARCH 2019, A TOTAL OF 949 PATIENTS (MEAN AGE: 13.1 ± 8.2 YEARS; 574 MALE AND 375 FEMALE PATIENTS) UNDERWENT VARIOUS INTERVENTIONS WHICH INVOLVED VENOUS ACCESS REQUIRING HEMOSTASIS. IN GROUP I (THE FELLOW¿S STITCH GROUP), A VICRYL 0 SUTURE (ETHICON) ON A LARGE-CURVED CUTTING NEEDLE WAS PASSED LITTLE DISTAL (5 - 10 MM) TO ENTRY POINT OF SHEATH INTO SKIN BELOW THE SHEATH AND ADVANCED THROUGH THE SUBCUTANEOUS TISSUE HOLDING ITS GENEROUS AMOUNT BUT WITHOUT GOING TOO DEEP TO LIGATE THE FEMORAL VEIN. REPORTED COMPLICATIONS INCLUDED HEMATOMA (N-1), RE-BLEEDING (N-5), STITCH FAILURE AS A RESULT OF SNAPPING OF SUTURE DURING KNOTTING (N-5). WITH THE INCREASING USE OF ANTICOAGULATION AND ANTIPLATELET AGENTS DURING VARIOUS CARDIAC CATHETERIZATION PROCEDURES, THE RATE OF LOCAL ACCESS SITE COMPLICATIONS HAS INCREASED. MANUAL COMPRESSION HAS BEEN THE GOLD STANDARD TO ACHIEVE HEMOSTASIS. SUBCUTANEOUS TEMPORARY ¿FELLOW¿S STITCH¿ IS A SIMPLE, CLINICALLY COST EFFECTIVE, EFFICACIOUS AND SAFE TECHNIQUE TO ACHIEVE IMMEDIATE POST-PROCEDURE VENOUS HEMOSTASIS FOR SHEATH SIZES AT LEAST UP TO 14 FR AMONG WIDE VARIETY OF POPULATION GROUP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443788 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1