BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONOVA* POLY (HEXAFLUOROPROPYLENE - VDF) SUTURE

    MDR report key: 3724847 · Received April 3, 2014

    Report

    Report Number
    2210968-2014-04233
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: ONE LOOSE DETACHED NEEDLE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. UPON EVALUATION, THE DEVICE WAS FOUND TO HAVE CORRECT SWAGE AND GOOD SWAGE COMPRESSION. NO SUTURE REMNANT WAS FOUND IN BARREL. THE DETACHED SUTURE WAS NOT RECEIVED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR STRENGTH AND THEY MET REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2014 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING OF THE BLOOD VESSEL, THE NEEDLE PULLED OFF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH THE OPPOSING SIDE OF THE DOUBLE ARMED SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202509 PRONOVA* POLY (HEXAFLUOROPROPYLENE - VDF) SUTURE SUTURE, NON ABSORBABLE, SYNTHETIC GAW ETHICON INC. UNK GGB591

    Patients

    Seq Age Sex Outcome Treatment
    1