BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

    MDR report key: 2411478 · Received January 11, 2012

    Report

    Report Number
    3005099803-2012-00021
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THE PROXIMAL END OF THE THERMOFORMED TUBING TO BE STRETCHED AND THE OUTER DIAMETER TO BE NECKED DOWN TO APPROXIMATELY .048 INCHES SPECIFICATION IS .073 ± .005 INCH. THE LENGTH WAS MEASURED TO APPROXIMATELY 41.9 INCHES; SPECIFICATION IS 39.4 ± 1.0 INCHES. THE OUTER DIAMETER OF THE TRANSITION JOINT WAS MEASURED TO BE APPROXIMATELY 0.9 CM AND FOUND TO BE WITHIN SPECIFICATIONS. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT CUSTOMER HAD DIFFICULTY PLACING THE FEEDING TUBE. BASED ON THE EVENT DESCRIPTION AND THE EVALUATION OF THIS AND OTHER SIMILAR RETURNED DEVICES, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT NUMBER 14344852 WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THE REPORTED COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 14344852.

    Additional Manufacturer Narrative · 1

    (B)(4):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 WHEN THE PHYSICIAN WAS PUSHING THE PEG TUBE OVER THE GUIDEWIRE THE CONNECTION PIECE ON THE TUBE GOT STUCK IN THE GASTRIC WALL AND WOULD NOT GO THROUGH THE STOMA SITE. THE PHYSICIAN REMOVED THE DEVICE THROUGH THE MOUTH. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. 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 FINE.

    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 WHEN THE PHYSICIAN WAS PUSHING THE PEG TUBE OVER THE GUIDEWIRE THE CONNECTION PIECE ON THE TUBE GOT STUCK IN THE GASTRIC WALL AND WOULD NOT GO THROUGH THE STOMA SITE. THE PHYSICIAN REMOVED THE DEVICE THROUGH THE MOUTH. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566490 14344852

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR