BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 11266145 · Received February 2, 2021

    Report

    Report Number
    2210968-2021-00962
    Event Type
    Injury
    Date Received
    February 2, 2021
    Date of Event
    December 1, 2020
    Report Date
    January 11, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (BLAKE DRAIN 15FR, J-VAC RESERVOIR AND BLAKE DRAIN 19FR) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? BLAKE DRAIN 15FR, J-VAC RESERVOIR: ATELECTASIS, PNEUMONIA, LEFT PLEURAL EFFUSION, PNEUMOTHORAX, CHYLE LEAKAGE, ATRIAL FIBRILLATION, ANASTOMOTIC LEAK, GASTRIC OUTLET OBSTRUCTION, HEMOTHORAX. BLAKE DRAIN 19FR: ATELECTASIS, PNEUMONIA, LEFT PLEURAL EFFUSION, PNEUMOTHORAX, ATRIAL FIBRILLATION, ANASTOMOTIC LEAK, AIR LEAKAGE) IF YES, PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (BLAKE DRAIN 15FR, J-VAC RESERVOIR AND BLAKE DRAIN 19FR) USED IN THIS PROCEDURE? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS: BLAKE DRAIN 15FR, J-VAC RESERVOIR: ATELECTASIS, PNEUMONIA, LEFT PLEURAL EFFUSION, PNEUMOTHORAX, CHYLE LEAKAGE, ATRIAL FIBRILLATION, ANASTOMOTIC LEAK, GASTRIC OUTLET OBSTRUCTION, HEMOTHORAX. BLAKE DRAIN 19FR: ATELECTASIS, PNEUMONIA, LEFT PLEURAL EFFUSION, PNEUMOTHORAX, ATRIAL FIBRILLATION, ANASTOMOTIC LEAK, AIR LEAKAGE. WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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. NOTE: EVENTS REPORTED ON MW# 2210968-2021-00963, MW# 2210968-2021-00964. CITATION: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES VOLUME 28, NUMBER 5, 2018 DOI: 10.1089/LAP.2018.0031. 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 · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT A DRAIN WAS USED. TITLE: OUTCOMES OF TRANSHIATAL AND INTERCOSTAL PLEURAL DRAIN AFTER IVOR LEWIS ESOPHAGECTOMY: COMPARATIVE ANALYSIS OF TWO CONSECUTIVE PATIENT COHORTS. AUTHOR: EMANUELE ASTI, MD, DANIELE BERNARDI, MD, GIANLUCA BONITTA, MSC, AND LUIGI BONAVINA, MD. CITATION: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES VOLUME 28, NUMBER 5, 2018. DOI: 10.1089/LAP.2018.0031. THE AIM OF THIS OBSERVATIONAL RETROSPECTIVE COHORT STUDY WAS TO COMPART THE SHOT-TERM OUTCOMES OF TRANSHIATAL AND INTERCOSTAL PLEURAL DRAINAGE. BETWEEN JANUARY 2014 AND DECEMBER 2016, 50 PATIENTS WITH TRANSHIATAL DRAIN (MALE N=42, MEDIAN AGE N=64, MEDIAN BMI=25.7) AND 50 WITH INTERCOSTAL DRAINS (MALE N=40, MEDIAN AGE N=61, MEDIAN BMI= 25.4) MET THE CRITERIA FOR INCLUSION IN THE STUDY AND UNDERWENT HYBRID IVOR LEWIS ESOPHAGECTOMY THROUGH LAPAROSCOPY AND RIGHT THORACOTOMY. PATIENTS WERE TREATED WITH A CONVENTIONAL INTERCOSTAL PLEURAL DRAINAGE UNTIL MAY 2015, AND WITH A TRANSHIATAL DRAIN THEREAFTER. IN THE INTERCOASTAL GROUP, A 19FR BLAKE DRAIN (ETHICON) WAS CONNECTED TO AN UNDERWATER SEAL AND CONTINUOUS SUCTION AND IN THE TRANSHIATAL, A 15FR BLAKE (ETHICON) WAS CONNECTED TO A PORTABLE VACUUM DRAINAGE SYSTEM- J-VAC (ETHICON). PERIOPERATIVE COMPLICATIONS INCLUDED ATELECTASIS (INTERCOASTAL N= 3, TRANSHIATAL N=1), PNEUMONIA (INTERCOASTAL N= 3, TRANSHIATAL N=1), LEFT PLEURAL EFFUSION (INTERCOASTAL N= 7, TRANSHIATAL N=9), PNEUMOTHORAX (INTERCOASTAL N= 1, TRANSHIATAL N=2), AIR LEAKAGE (INTERCOASTAL N= 1), CHYLE LEAKAGE (TRANSHIATAL N=1), ATRIAL FIBRILLATION (INTERCOASTAL N= 2, TRANSHIATAL N=3) , ANASTOMOTIC LEAK (INTERCOASTAL N= 2, TRANSHIATAL N=1), GASTRIC OUTLET OBSTRUCTION (TRANSHIATAL N=4), HEMOTHORAX (TRANSHIATAL N=1) AND DINDO-CLAVIEN GRADE >3A (INTERCOASTAL N= 2, TRANSHIATAL N=2). TRANSHIATAL PLEURAL DRAINAGE CONNECTED TO A PORTABLE VACUUM SYSTEM COULD SAFELY REPLACE THE INTERCOSTAL DRAIN AFTER HYBRID IVOR LEWIS ESOPHAGECTOMY. IT HAS THE POTENTIAL TO REDUCE POSTOPERATIVE PAIN AND USE OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS, AND TO ENHANCE RECOVERY FROM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165141 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention