BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1920631 · Received December 13, 2010

    Report

    Report Number
    3005099803-2010-05115
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Product Problem
    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.(B)(4):THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    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 AN INITIAL G-TUBE WAS USED IN CONJUNCTION WITH A TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) FOR THE PURPOSES OF ADMINISTERING MEDICATION FOR THE ADVANCED STAGE OF PARKINSON'S DISEASE, (EXACT UPN IS UNKNOWN). THE DEVICE WAS PLACED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2010 THE G-TUBE BECAME OCCLUDED, THERE WAS A LITTLE HOLE IN THE MIDDLE BETWEEN THE EXTERNAL BUMPER AND THE J-TUBE CONNECTOR. IT WAS NOTED THAT THERE WAS LEAKAGE OF STOMACH FLUID. THE PATIENT DID NOT EXPERIENCE ANY HEALTH RELATED IMPAIRMENT DUE TO THIS EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INITIAL G-TUBE WAS USED IN CONJUNCTION WITH A TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) FOR THE PURPOSES OF ADMINISTERING MEDICATION FOR THE ADVANCED STAGE OF PARKINSON'S DISEASE, (EXACT UPN IS UNKNOWN). THE DEVICE WAS PLACED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2010 THE G-TUBE BECAME OCCLUDED, THERE WAS A LITTLE HOLE IN THE MIDDLE BETWEEN THE EXTERNAL BUMPER AND THE J-TUBE CONNECTOR. IT WAS NOTED THAT THERE WAS LEAKAGE OF STOMACH FLUID. THE PATIENT DID NOT EXPERIENCE ANY HEALTH RELATED IMPAIRMENT DUE TO THIS EVENT. 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. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 22, 2010: THE PATIENT RECEIVED A NEW INITIAL G-TUBE IN CONJUNCTION WITH A TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 75 YR