BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1834251 · Received September 14, 2010

    Report

    Report Number
    3005099803-2010-03957
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    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

    (B)(4): 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. (B)(4)

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE PULLWIRE TIP 18/20 FR ON THE END OF THE PEG DEVICE WAS FOUND TO BE BROKEN. THE WIRE ENDS WERE FRAYED NOT CUT. WIRE APPEARS TO HAVE FAILED WHILE UNDERGOING TENSILE LOAD. THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE PULLWIRE TIP BROKE. A REVIEW OF THE SUB-ASSEMBLY PULLWIRE TIP 18/20 FR DHR REVEALED NO ANOMALIES IN MATERIAL OR MANUFACTURING. THERE WAS NO EVIDENCE THAT THE PEG TUBE INSERTION WIRE CONNECTION WAS NOT COMPLETED PROPERLY OR THAT SOME DIMENSIONAL FEATURE WAS OUT OF SPECIFICATION. IT IS POSSIBLE THAT THE STOMA SITE WAS NOT OPENED TO THE SIZE SPECIFIED IN DFU LEADING TO RESISTANCE WHEN PLACING THE DEVICE. BECAUSE THE WIRE FAILED IN TENSION DURING THE PEG PLACEMENT, THE MOST PROBABLE ROOT CAUSE IS OPERATION CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KITS PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE METAL LOOP ON THE END OF THE PEG TUBE BROKE IN HALF INSIDE THE PATIENT. NO PART OF THE DEVICE CAME OFF IN THE PATIENT. THE PHYSICIAN WAS UNABLE TO PULL THE TUBE THROUGH THE STOMACH; THE PEG WAS REMOVED THROUGH THE PATIENT'S MOUTH VIA THE PHYSICIAN'S HAND. THE BOLSTER WAS JUST ENTERING THE PATIENT'S MOUTH WHEN THE WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KITS PULL 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 KITS PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE METAL LOOP ON THE END OF THE PEG TUBE BROKE IN HALF INSIDE THE PATIENT. NO PART OF THE DEVICE CAME OFF IN THE PATIENT. THE PHYSICIAN WAS UNABLE TO PULL THE TUBE THROUGH THE STOMACH; THE PEG WAS REMOVED THROUGH THE PATIENT'S MOUTH VIA THE PHYSICIAN'S HAND. THE BOLSTER WAS JUST ENTERING THE PATIENT'S MOUTH WHEN THE WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KITS PULL 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 M00566721 13428122

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR