BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1900722 · Received November 16, 2010

    Report

    Report Number
    3005099803-2010-04740
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE REVEALED THE TUBE TO HAVE BEEN CUT AT APPROXIMATELY THE 8 CENTIMETER MARK. THE PROXIMAL PORTION OF THE DEVICE WAS NOT RETURNED. THE TUBE WAS BROKEN AT APPROXIMATELY THE 2.5 CENTIMETER MARK. BOTH SECTIONS OF THE FAILED TUBING HAVE SCRAPE MARKS ON THE INNER WALL. THE PROXIMAL SECTION OF THE TUBING HAS INTERNAL SCRAPE MARKS THE FULL LENGTH OF THE RETURNED SECTION. THE DISTAL SECTION HAS INTERNAL SCRAPE MARKS NEAR THE FRACTURE AND THEY ARE MORE PRONOUNCED IN THE BREAK AREA. THE FRACTURED END OF THE TUBING WERE JAGGED WITH PERPENDICULAR TEARS. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE TUBING SEPARATED. PHYSICAL ANALYSIS OF THE DEVICE REVEALED THE TUBING TO HAVE BEEN SCRAPED INTERNALLY BY ANOTHER UNKNOWN DEVICE. BASED ON THE EVENT DESCRIPTION AND EVALUATION OF THE RETURNED DEVICE, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE.

    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. (B)(4) - RETRIEVAL OF DEVICE COMPONENT. (B)(4) - THE REPORTED EVENT OF TUBE BROKE. THE DEVICE HAS 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 PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE, (EXACT DATE UNKNOWN HOWEVER THREE MONTHS PRIOR TO EVENT DATE). ACCORDING TO THE COMPLAINANT, ON (B)(6), 2010, WHILE REMOVING THE INITIAL DEVICE TO PREPARE FOR REPLACEMENT, THE PHYSICIAN APPLIED JELLY AROUND THE STOMA SITE AND PULLED UPWARD ON THE PEG TUBE. THE PEG TUBE BROKE AND THE INTERNAL BOLSTER WAS RETRIEVED WITH A SCOPE AND SNARE. NOTHING REMAINED IN PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PULL METHOD. 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 AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE, (EXACT DATE UNKNOWN HOWEVER THREE MONTHS PRIOR TO EVENT DATE). ACCORDING TO THE COMPLAINANT, ON (B)(6) 2010, WHILE REMOVING THE INITIAL DEVICE TO PREPARE FOR REPLACEMENT, THE PHYSICIAN APPLIED JELLY AROUND THE STOMA SITE AND PULLED UPWARD ON THE PEG TUBE. THE PEG TUBE BROKE AND THE INTERNAL BOLSTER WAS RETRIEVED WITH A SCOPE AND SNARE. NOTHING REMAINED IN PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PULL METHOD. 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
    1 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566521

    Patients

    Seq Age Sex Outcome Treatment
    1 Other