BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOOP LIGATURE

    MDR report key: 2032709 · Received March 17, 2011

    Report

    Report Number
    2210968-2011-00289
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 12, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH CKS170, MFG DATE: 09/10/2010, EXP DATE: 09/30/2015. BATCH CLS209, MFG DATE: 10/01/2010, EXP DATE: 10/31/2015. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A MEDIASTINAL TUMOR RESECTION ON (B)(6) 2011 AND SUTURE WAS USED. ON (B)(6) 2011, THE PT DEVELOPED CHEST PAIN, BLOOD PRESSURE DROPPED TO 50MM HG, CARDIAC TAMPONADE WAS DIAGNOSED AND THE PT WENT BACK TO THE HOSPITAL. PERICARDIAL DRAINAGE WAS PERFORMED AND 700ML OF HEMATOGENOUS CARDIAC EFFUSION WAS DISCHARGED. ON (B)(6) 2011, A REOPERATION WAS PERFORMED AND THE SURGEON CONFIRMED THAT THE CARDIAC MUSCLE WAS CUT THROUGH THE PERICARDIAL MEMBRANE BY THE CUT END OF THE SUTURE AND WAS BLEEDING. THE LOCATION WAS AT THE RIGHT VENTRICULAR BRANCH OF THE RIGHT CORONARY ARTERY. THE SUTURE WAS REMOVED AND THE BLEEDING POINT WAS RE-SUTURED WITH A DIFFERENT SUTURE. HEMOSTASIS WAS ACHIEVED. THE PT IS STABLE. THE SURGEON OPINES THAT THE SUTURE THREAD WAS TOO THICK AND THE CUT END OF THE SUTURE BECAME SHARP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLOOP LIGATURE ABSORBABLE SUTURE GAM ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention