BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE¿ SAFETY PEG KIT

    MDR report key: 2983069 · Received February 28, 2013

    Report

    Report Number
    3005099803-2013-01134
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF WIRE BROKE FROM HANDLE. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WOULD NOT CLOSE THE WIRE BROKE FROM THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SNARE IN CONJUNCTION WITH THIS PEG KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85625 ENDOVIVE¿ SAFETY PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566460 15768622

    Patients

    Seq Age Sex Outcome Treatment
    1