BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE¿ ONE STEP BUTTON¿

    MDR report key: 6137712 · Received December 1, 2016

    Report

    Report Number
    3005099803-2016-03661
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 10, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KGC
    UDI-DI
    08714729284161
    PMA / PMN Number
    K910584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE DEVICE HAD SEPARATED INTO TWO PIECES. THE SHEATH WAS SPLIT AS THOUGH BY A SHARP OBJECT. IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THE BUTTON TUBE DELIVERY SYSTEM BECAME DETACHED/SEPARATED. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE IS "OPERATIONAL CONTEXT". A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND THERE IS NO EVIDENCE THAT THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PEG PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THE TUBE WAS BEING PULLED TO THE STOMA SITE, THE CATHETER SHEATH BROKE INSIDE THE PATIENT. EVERYTHING WAS RETRIEVED AND NO PARTS OF THE DEVICE WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY 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 NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PEG PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THE TUBE WAS BEING PULLED TO THE STOMA SITE, THE CATHETER SHEATH BROKE INSIDE THE PATIENT. EVERYTHING WAS RETRIEVED AND NO PARTS OF THE DEVICE WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY 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 NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789076 ENDOVIVE¿ ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY KGC BOSTON SCIENTIFIC - SPENCER M00563030 18851017 08714729284161

    Patients

    Seq Age Sex Outcome Treatment
    1 Other