BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONOVA* POLY (HEXAFLUOROPROPYLENE - VDF) SUTURE

    MDR report key: 3846079 · Received June 3, 2014

    Report

    Report Number
    2210968-2014-06998
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K001625
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. FUNCTIONAL EVALUATION WAS PERFORMED AND THE SAMPLES MET THE REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2014 AND SUTURE WAS USED TO CLOSE THE VESSELS. DURING THE PROCEDURE THE SUTURE BROKE IT WAS REPORTED THAT, ¿DURING CABG SURGERY, SURGEON USED 3702H TO CLOSE THE VESSELS AND BROKEN AS 2 PIECE AFTER TYING KNOTS. ¿ THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324448 PRONOVA* POLY (HEXAFLUOROPROPYLENE - VDF) SUTURE SUTURE, NON ABSORBABLE, SYNTHETIC GAW ETHICON INC. UNK GME454

    Patients

    Seq Age Sex Outcome Treatment
    1