BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7426457 · Received April 12, 2018

    Report

    Report Number
    2210968-2018-72110
    Event Type
    Injury
    Date Received
    April 12, 2018
    Report Date
    April 3, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? -NO. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PDS SUTURE PRODUCTS USED IN THIS PROCEDURE? .SORRY WE COULDN'T GET INFORMATION ANY MORE. CITATION: THORACIC SURGERY. 2013; 66(7). (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: CORONARY ARTERY INJURY BY CUTTING EDGE OF ESOPHAGEAL SUTURE THREAD AUTHORS: HIROAKI KURODA, KIMIYO ONO CITATION: THORACIC SURGERY. 2013; 66(7). AFTER DERMAL SUTURING WITH MONOFILAMENT SUTURE, THE STUMP PROTRUDES FROM THE SKIN. THERE ARE TIMES WHEN IT TOUCHES HARD LIKE A WIRE. THE AUTHORS REPORTED A (B)(6) WOMAN WHO UNDERWENT A THORASCOPIC EXCISION OF THE DIVERTICULUM OF THE ESOPHAGUS AND HAD CARDIAC TAMPONADE 13-DAYS POST-OPERATIVELY. DURING THE EMERGENCY OPEN SURGERY, AN ACTIVE ARTERIAL BLEEDING WAS SEEN AT THE MARGINAL BRANCH OF THE LEFT CIRCUMFLEX CORONARY ARTERY. THE STUMP OF THE PDS 4-0 SUTURE WHICH HAD BEEN USED FOR CLOSURE OF THE OVERLYING ESOPHAGEAL MUSCLE LAYER, PENETRATED THE PERICARDIUM AND INJURED THE CORONARY ARTERY. IT WAS REPORTED THAT VESSEL INJURY CAUSED BY A STUMP OF A SUTURE SEEMS TO BE EXTREMELY RARE. CAREFUL SELECTION OF THE SUTURE AROUND THE PERICARDIUM AND MANAGEMENT OF ITS STUMP ARE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266996 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention