BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONOVA BLUE SUTURE UNKNOWN PRODUCT

    MDR report key: 11050922 · Received December 21, 2020

    Report

    Report Number
    2210968-2020-10142
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    January 11, 2019
    Report Date
    December 3, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K001625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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 ETHICON PRODUCTS (PRONOVA SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED (CSF RHINORRHEA, HYPOPITUITARISM) IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PRONOVA SUTURE) USED IN THIS PROCEDURE? DID THE PATIENTS THAT EXPERIENCED THE CSF RHINORRHEA, HYPOPITUITARISM UNDERGO THE CLIPPING TECHNIQUE OF TYPE 1 CSF LEAKAGE, AND WAS ETHICON DEVICE (PRONOVA SUTURE) UTILIZED FOR THESE PATIENTS? PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS LISTED ABOVE. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: OPERATIVE NEUROSURGERY 17:382¿388, 2019. DOI: 10.1093/ONS/OPY408.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: CLIPPING TECHNIQUE FOR THE REPAIR OF THE INTRAOPERATIVE CEREBROSPINAL FLUID LEAKAGE DURING TRANSSPHENOIDAL PITUITARY TUMOR SURGERY". AUTHOR: EUI HYUN KIM,MD, PHD, JU HYUNG MOON, MD AND SUN HO KIM,MD, PHD. CITATION: OPERATIVE NEUROSURGERY 17:382¿388, 2019. DOI: 10.1093/ONS/OPY408. THIS RETROSPECTIVE STUDY EVALUATES THE USEFULNESS OF A NEWLY DEVELOPED CLIPPING TECHNIQUE FOR THE REPAIR OF INTRAOPERATIVE CSF LEAKAGE. BETWEEN SEPTEMBER 2012 AND NOVEMBER 2016, PATIENTS WITH PITUITARY ADENOMA WERE OPERATED ON WITH TRANSSPHENOIDAL SURGERY (TSS). THE CLIPPING TECHNIQUE WAS USED IN 144 PATIENTS (46 MALES, 98 FEMALES, MEAN AGE WAS 45.6 YEARS AND RANGE OF 17-73 YEARS) WITH CSF LEAKAGE FROM THE ARACHNOID RECESS (TYPE 1 CSF LEAKAGE, N = 100) AND A DEFECT IN THE ARACHNOID MEMBRANE (TYPE 2-4 CSF LEAKAGE, N = 44). FOR THE CLIPPING TECHNIQUE OF TYPE 1 CSF LEAKAGE, WHEN THE GAP BETWEEN TWO LAYERS WAS QUITE WIDE THAT CSF LEAKAGE WAS APPARENT FROM AN IDENTIFIABLE TEARING POINT, THE ANTERIOR EDGE OF THE NORMAL GLANDULAR TISSUE THAT ATTACHED ONTO THE ARACHNOID MEMBRANE WAS LIFTED, PLACED IT ONTO THE DURAL MARGIN, AND MADE 1 OR 2 SUTURES USING 7-0 PRONOVA (ETHICON) AND SUTURE-TYING FORCEPS. POSTOPERATIVE CSF RHINORRHEA (N=4) AND AGGRAVATION OF HYPOPITUITARISM (N=15) WERE REPORTED. ALL OF THESE PATIENTS WHO HAD POSTOPERATIVE CSF RHINORRHEA UNDERWENT REOPERATION. OUR CLIPPING TECHNIQUE IS A VERY CONVENIENT AND RELIABLE METHOD FOR THE REPAIR OF INTRAOPERATIVE CSF LEAKAGE WHEN PROPERLY APPLIED WITH CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513776 PRONOVA BLUE SUTURE UNKNOWN PRODUCT SUTURE, NON ABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention