BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE¿ LOW PROFILE REPLACEMENT BUTTON

    MDR report key: 2771687 · Received October 4, 2012

    Report

    Report Number
    3005099803-2012-04646
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE IS UNKNOWN, IT WAS REPORTED TO BE OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE REPORTED EVENT OF THE TUBE WAS BLOCKED WITH MEDICINE. THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A PHYSICAL EXAMINATION FOUND A WHITE PILL WEDGED INSIDE THE BUTTON BODY. NO VISIBLE ISSUES WERE NOTED WITH THE DEVICE. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BUTTON FEEDING TUBE WAS CLOGGED WITH MEDICATION. DIRECTIONS FOR USE PROVIDED WITH THIS DEVICE LISTS BLOCKAGE/OCCLUSION AND TUBE CLOGGING AS POTENTIAL ADVERSE EFFECTS. ADDITIONALLY THE PATIENT CARE GUIDE SUPPLIED WITH THIS KIT PROVIDES THE FOLLOWING GUIDANCE: "GIVING MEDICATIONS (IF PRESCRIBED), MEDICATIONS MAY BE GIVEN THROUGH THE FEEDING TUBE IF THE DOCTOR ALLOWS. ASK THE DOCTOR TO ORDER PRESCRIPTIONS IN LIQUID FORM, IF POSSIBLE. IF THE MEDICATION IS IN TABLET OR CAPSULE FORM, DISSOLVE THE PRESCRIBED AMOUNT IN 30-50CC (15-30CC FOR CHILDREN) OF WARM WATER IN A SMALL MEDICATION CUP." THE USER FAILED TO DISSOLVE THE TABLET PRIOR TO ADMINISTRATION BUT INSERTED THE WHOLE TABLET INTO THE BUTTON BODY. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS USER/ USE ERROR.

    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 A REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2012, IT BECAME DIFFICULT TO ADMINISTER THE NUTRITIONAL SUPPLEMENT. ON (B)(6) 2012, IT BECAME UNABLE TO ADMINISTER THE NUTRITIONAL SUPPLEMENT. THE PLACED DEVICE WAS REMOVED ON (B)(6) 2012 AND REPLACED WITH A DIFFERENT DEVICE. THE SALES REPRESENTATIVE CHECKED THE DEVICE AFTER REMOVAL AND NOTICED THAT THE TUBE WAS CLOGGED WITH MEDICINE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THIS EVENT WAS REPORTED TO BE GOOD.

    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 A REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2012, IT BECAME DIFFICULT TO ADMINISTER THE NUTRITIONAL SUPPLEMENT. ON (B)(6) 2012, IT BECAME UNABLE TO ADMINISTER THE NUTRITIONAL SUPPLEMENT. THE PLACED DEVICE WAS REMOVED ON (B)(6) 2012 AND REPLACED WITH A DIFFERENT DEVICE. THE SALES REPRESENTATIVE CHECKED THE DEVICE AFTER REMOVAL AND NOTICED THAT THE TUBE WAS CLOGGED WITH MEDICINE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THIS EVENT WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE¿ LOW PROFILE REPLACEMENT BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568290

    Patients

    Seq Age Sex Outcome Treatment
    1 MAGNESIUM OXIDE| BENIDIPINE| LEVOTHYROXINE SODIUM HYDRATE