BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

    MDR report key: 3180686 · Received June 20, 2013

    Report

    Report Number
    3005099803-2013-05797
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INITIAL PLACEMENT KIT WAS USED DURING A PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, AFTER POSITIONING PEG/ PEJ TUBE ON (B)(6) 2013, THE PATIENT PROLONGED HOSPITALIZATION AT THE HOSPITAL OF TRENTO FOR PNEUMONIA AND PERITONITIS (TREATED WITH ANTIBIOTIC THERAPY UNSPECIFIED) UNTIL (B)(6), 2013. THEN THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY IN NEUROREHABILITATION OF ROVERETO AND ON (B)(6) 2013 THE PATIENT WAS TRANSFERRED BACK TO TRENTO TO WORSENING OF THE NEUROLOGICAL (PATIENT AT TIMES SOMNOLENT AND OTHER TIMES AGGRESSIVE). THERE IS NO INFORMATION AVAILABLE FOR THE PROCEDURE OUTCOME. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 THAT THERE WAS NO ALLEGED MALFUNCTION OF THE DEVICE: THE PERITONEAL CHEMICAL WAS DUE TO LEAKAGE OF GASTRIC CONTENTS INTO THE PERITONEUM DUE TO COMPLICATION OF ENDOSCOPIC PROCEDURE. THEREFORE, THE PATIENT'S PNEUMONIA WAS NOT CAUSED BY THE PEG/J TUBE. THERE IS NO QUALITY ISSUE OF TUBING AS REPORTED BY CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOVIVE INITIAL PLACEMENT KIT WAS USED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE DATE IS ALSO UNKNOWN. ACCORDING TO THE COMPLAINANT, AFTER POSITIONING PEG/ PEJ TUBE ON (B)(6) 2013, THE PATIENT PROLONGED HOSPITALIZATION AT THE HOSPITAL OF TRENTO FOR PNEUMONIA AND PERITONITIS (TREATED WITH ANTIBIOTIC THERAPY UNSPECIFIED) UNTIL (B)(6) 2013. THEN THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY IN NEUROREHABILITATION OF ROVERETO AND ON (B)(6) 2013, THE PATIENT WAS TRANSFERRED BACK TO TRENTO TO WORSENING OF THE NEUROLOGICAL (PATIENT AT TIMES SOMNOLENT AND OTHER TIMES AGGRESSIVE). THERE IS NO INFORMATION AVAILABLE FOR THE PROCEDURE OUTCOME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279896 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER UNK518

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization