BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 10849273 · Received November 16, 2020

    Report

    Report Number
    2210968-2020-09079
    Event Type
    Injury
    Date Received
    November 16, 2020
    Date of Event
    June 12, 2020
    Report Date
    October 27, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 12/18/2020. ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. 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.

    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 PRODUCTS (PDS II SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (LEAKAGE FROM THE LEFT HEPATIC DUCT AND SMALL LEAKAGE OF CONTRAST IN THE RIGHT BILIARY TREE) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PDS II SUTURE) USED IN THIS PROCEDURE? WAS THIS CASE OF (B)(6) YEARS CAUCASIAN MALE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS 72 (2020) 386¿390 / HTTPS://DOI.ORG/10.1016/J.IJSCR.2020.06.049. 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

    TITLE: BICYCLE HANDLEBAR INJURY IN A CHILD RESULTING IN COMPLEX LIVER LACERATION WITH MASSIVE BLEEDING AND BILE LEAKAGE: A CASE REPORT. THE PURPOSE OF THIS CASE REPORT IS TO DESCRIBE THE CLINICAL PRESENTATION, MANAGEMENT AND OUTCOME OF HANDLEBAR INJURY (HBI) CAUSING SEVERE LIVER LACERATION WITH HAEMORRHAGE AND LEFT HEPATIC DUCT INJURY IN A YOUNG BOY. A (B)(6)-YEAR-OLD CAUCASIAN MALE PATIENT PRESENTED TO OUR SURGICAL EMERGENCY DEPARTMENT WITH COMPLAINTS OF SEVERE DIFFUSE ABDOMINAL PAIN AND DISTENSION. THE PATIENT HAD A DIRECT BLOW TO THE UPPER RIGHT QUADRANT OF HIS ABDOMEN FROM A BICYCLE HANDLEBAR. ABDOMINAL EXAMINATION WAS REMARKABLE FOR SIGNIFICANT DISTENSION AND DIFFUSE TENDERNESS. FAST SCAN WAS PERFORMED, SHOWING DIFFUSE ECHOGENIC FREE FLUID INTRAPERITONEALLY WITH THE MOST PROBABLE CAUSE BEING HEMOPERITONEUM. DUE TO THE EXTENSIVE INTRAPERITONEAL FREE FLUID SEEN ON FAST AND THE PERSISTING FEATURES OF HAEMODYNAMIC INSTABILITY (TACHYCARDIA, PALLOR), A DECISION FOR IMMEDIATE EXPLORATORY LAPAROTOMY WAS MADE. AN EMERGENCY UPPER MEDIAN LAPAROTOMY WAS PERFORMED UNDER GENERAL ANAESTHESIA TO DETERMINE THE EXACT NATURE OF THE ABDOMINAL INJURY. DURING THE EXPLORATION, A DEEP LACERATION ALMOST SEPARATING LEFT AND RIGHT LIVER LOBES WAS FOUND WITH EVIDENT BLEEDING FROM THE LACERATION (GRADE II-III ACCORDING TO AAST LIVER INJURY SCALE). A METICULOUS EXAMINATION OF THE LACERATION WAS DONE, AND AN INJURY OF THE LEFT HEPATIC DUCT WAS OBSERVED. A DUCT-TO-DUCT ANASTOMOSIS OF THE INJURED LEFT HEPATIC DUCT WAS PERFORMED WITH 6.0 PDS (ETHICON) INTERMITTENT SUTURES. AT THE END OF THE OPERATION, HEMOSTATIC ABSORBABLE WRAPS SURGICEL (ETHICON) WERE INSERTED INTO THE LIVER LACERATION. ON THE SECOND POSTOPERATIVE DAY, AN US SCAN WAS PERFORMED, SHOWING MINIMAL FREE FLUID IN THE PERITONEAL CAVITY UNDER THE LIVER. ON THE FIFTH POSTOPERATIVE DAY, AN US SCAN WAS REPEATED, THERE WAS AN INTRAHEPATIC FLUID COLLECTION DESCRIBED AT THE POINT OF LIVER LACERATION. CHOLANGIOGRAPHY IMAGING WAS PERFORMED THROUGH THE T-TUBE TO EXCLUDE BILIARY LEAKAGE. THE CHOLANGIOGRAPHY REVEALED EVIDENT LEAKAGE FROM THE LEFT HEPATIC DUCT, WITH THE SIZE AND LOCATION OF THE EXTRAVASATED CONTRAST CORRESPONDING TO THE PREVIOUSLY DESCRIBED FLUID COLLECTION ON US. FURTHERMORE, A SMALL LEAKAGE OF CONTRAST WAS SEEN IN THE RIGHT BILIARY TREE. A DECISION WAS MADE TO MANAGE THE LEAKAGE OF BILE FROM LEFT AND RIGHT BILIARY TREE CONSERVATIVELY. THE T-TUBE WAS CONSEQUENTLY LEFT OPEN. ON THE EIGHTEENTH POSTOPERATIVE DAY AND 13 DAYS AFTER THE FIRST CHOLANGIOGRAPHY, A FOLLOW-UP CHOLANGIOGRAPHY WAS PERFORMED, WHICH SHOWED NO SIGNS OF LEAKAGE FROM BOTH THE LEFT AND RIGHT BILIARY TREES. LAST US FOLLOW-UP DURING HOSPITAL STAY WAS PERFORMED, THE SIZE OF THE COLLECTION DID NOT CHANGE AND THERE WERE NO SIGNS OF BILIARY OBSTRUCTION. THE PATIENT WAS ASYMPTOMATIC AND FEELING WELL, AND WE NOTED A DECLINE OF THE PREVIOUSLY ELEVATED LIVER ENZYMES (ALT AND ALT). CONSEQUENTLY, HE WAS DISCHARGED FROM THE HOSPITAL WITH A CLOSED T-TUBE IN PLACE. TRADITIONALLY, LAPAROTOMY AND HEPATICOJEJUNOSTOMY HAS BEEN THE GOLD STANDARD FOR TREATMENT OF BILIARY INJURIES. NEVERTHELESS, WE BELIEVE THAT IN A CASE OF A MAJOR TRANSECTION OF THE INTRAHEPATIC BILIARY DUCT, PRIMARY SUTURE AND DUCT-TO-DUCT ANASTOMOSIS IS FEASIBLE IF AN IMMEDIATE LAPAROTOMY IS MANDATORY DUE TO HEMODYNAMIC REASONS. IT IS OF VITAL IMPORTANCE TO ARREST HAEMORRHAGE AND ATTAIN HAEMODYNAMIC STABILITY PRIOR TO ATTEMPTING DUCTAL ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307944 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR