BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE? LOW PROFILE REPLACEMENT BUTTON

    MDR report key: 4221395 · Received November 3, 2014

    Report

    Report Number
    3005099803-2014-03439
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 9, 2014
    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

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. 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 DEVICE FOUND THE DOME TO HAVE BEEN SEPARATED FROM THE BODY. THE SEPARATION OCCURRED AT APPROXIMATELY 1.2 CM FROM THE FLANGE. AN EXAMINATION OF THE FAILED SURFACE FOUND MOST OF THE SURFACE TO BE SMOOTH. THE SURFACE ALSO PRESENTED WHAT APPEAR TO BE STRIATIONS FROM CUTTING BY SCALPEL OR SIMILAR INSTRUMENT. A SMALL PORTION OF THE EDGE APPEARS TO HAVE FAILED WHILE UNDERGOING TENSILE FORCE. ALTHOUGH THE DEVICE WAS COVERED IN RESIDUE, THE DEVICE MATERIAL DID NOT PRESENT ANY EVIDENCE OF DEGRADATION DURING IMPLANTATION IN THE PATIENT. IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT BUTTON BOLSTER WAS DETACHED. BASED ON ALL GATHERED INFORMATION THE MOST PROBABLE ROOT CAUSE IS "OPERATIONAL CONTEXT."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LOW PROFILE BUTTON REPLACEMENT G TUBE WAS USED DURING REPLACEMENT OF GASTROSTOMY TUBE PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, DURING THE PROCEDURE, THE INTERNAL BOLSTER DETACHED INSIDE THE PATIENT¿S STOMACH. ENEMA CLYSTER WAS PERFORMED TO THE PATIENT AND THE STOOL WAS REGULARLY MONITORED. TWO WEEKS LATER, THE DETACHED BOLSTER PASSED NATURALLY. THE PROCEDURE WAS COMPLETED WITH  A NEW LOW PROFILE BUTTON REPLACEMENT G TUBE. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LOW PROFILE BUTTON REPLACEMENT G TUBE WAS USED DURING REPLACEMENT OF GASTROSTOMY TUBE PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, DURING THE PROCEDURE, THE INTERNAL BOLSTER DETACHED INSIDE THE PATIENT¿S STOMACH. ENEMA CLYSTER WAS PERFORMED TO THE PATIENT AND THE STOOL WAS REGULARLY MONITORED. TWO WEEKS LATER, THE DETACHED BOLSTER PASSED NATURALLY. THE PROCEDURE WAS COMPLETED WITH A NEW LOW PROFILE BUTTON REPLACEMENT G TUBE. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701574 ENDOVIVE? LOW PROFILE REPLACEMENT BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568270

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR