BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE¿ SAFETY PEG KIT

    MDR report key: 2420047 · Received January 18, 2012

    Report

    Report Number
    3005099803-2012-00040
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    December 28, 2011
    Report Date
    December 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE PUSH INITIAL G-TUBE FOUND THE PROXIMAL END OF THE THERMOFORMED TUBING TO BE STRETCHED AND BROKEN. THE DETACHED PROXIMAL PORTION OF THE THERMOFORMED TUBING WAS MEASURED TO BE APPROXIMATELY 12 INCHES LONG. THE DISTAL SECTION OF THE THERMOFORMED TUBING WAS MEASURED TO BE APPROXIMATELY 34.5 INCHES FOR A COMBINED TOTAL OF 46.5 INCHES. SPECIFICATION IS 39.4 ± 1.0 INCHES. THE THERMOFORMED TUBING WAS TORN WITH THE BROKEN ENDS NECKED DOWN AND FRAYED. ADDITIONALLY THE PROXIMAL PORTION WAS STRETCHED AND OUTER DIAMETER NECKED DOWN TO APPROXIMATELY .052 INCH. SPECIFICATION OF THE OUTER DIAMETER IS .073 ± .005 INCH. NUMEROUS LONGITUDINAL CUT/ SCRAPE MARKS WERE FOUND AROUND THE CIRCUMFERENCE OF THE THERMOFORMED TUBING AT APPROXIMATELY 10 CM DISTAL THE BREAK AREA. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE FEEDING TUBE DETACHED/ SEPARATED. A PHYSICAL EXAMINATION OF THE DEVICE FOUND THE THERMOFORMED TUBING TO BE STRETCHED AND BROKEN MOST LIKELY IN AN ATTEMPT TO PLACE THE DEVICE. BASED ON THE EVENT DESCRIPTION AND THE EVALUATION OF THIS AND OTHER SIMILAR RETURNED DEVICES, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR LOT 14799280 AND REVEALED NO ISSUES RELATED TO THE REPORTED COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 14799280.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE THE PHYSICIAN WAS TRACKING THE PUSH PEG TUBE OVER THE GUIDEWIRE AS IT CAME THROUGH THE ABDOMEN THE PEG TUBE DETACHED OUTSIDE THE PATIENT. THE PHYSICIAN STATED THERE WERE NO OCCLUSIONS IN THE PATIENT'S GI TRACT THAT COULD HAVE CAUSE THIS. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2011.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE THE PHYSICIAN WAS TRACKING THE PUSH PEG TUBE OVER THE GUIDEWIRE AS IT CAME THROUGH THE ABDOMEN THE PEG TUBE DETACHED OUTSIDE THE PATIENT. THE PHYSICIAN STATED THERE WERE NO OCCLUSIONS IN THE PATIENT'S GI TRACT THAT COULD HAVE CAUSE THIS. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE¿ SAFETY PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566731 14799280

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR