BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE? STANDARD PEG KIT

    MDR report key: 4173861 · Received October 15, 2014

    Report

    Report Number
    3005099803-2014-03339
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 22, 2014
    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

    (B)(4). 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 ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2014, THE PEG TUBE WAS TORN AT THE STOMA SITE. THE PEG TUBE WAS REPLACED. 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 ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, THE PEG TUBE WAS TORN AT THE STOMA SITE. THE PEG TUBE WAS REPLACED. 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 (B)(4) 2014: THIS IS A SINGLE USE PRODUCT THAT WAS REPROCESSED BY THE HOSPITAL OR HEALTH CARE FACILITY THEREFORE THEY ARE NOW RESPONSIBLE FOR THIS DEVICE. PROCEDURE DATE IS (B)(6) 2013. NO PATIENT COMPLICATIONS. THE PATIENT RECOVERED AFTER THE ISSUE WAS RESOLVED. CORRECTION RECEIVED ON (B)(4) 2014: THE PEG TUBE WAS NOT RE-STERILIZED. "REPROCESSING" MEANT A NEW PEG TUBE WAS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, THE PEG TUBE WAS TORN AT THE STOMA SITE. THE PEG TUBE WAS REPLACED. 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 22OCT2014: THIS IS A SINGLE USE PRODUCT THAT WAS REPROCESSED BY THE HOSPITAL OR HEALTH CARE FACILITY THEREFORE THEY ARE NOW RESPONSIBLE FOR THIS DEVICE. PROCEDURE DATE IS (B)(6) 2013. NO PATIENT COMPLICATIONS. THE PATIENT RECOVERED AFTER THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656191 ENDOVIVE? STANDARD PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568380 14366668

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other DUODOPA