BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE¿ SAFETY PEG KIT

    MDR report key: 2945762 · Received February 6, 2013

    Report

    Report Number
    3005099803-2013-00655
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE FOUND THE SILICONE TUBING TO HAVE BEEN CUT AT APPROXIMATELY 40 CM PROXIMAL THE OUTER RING AND THE DISTAL PORTION OF THE DEVICE AS NOT RETURNED. NO ISSUES WERE NOTED WITH THE TUBING, CONNECTOR AND INNER AND OUTER RINGS. AN EXAMINATION OF THE DILATING TIP FOUND THE WIRE LOOP TO BE BROKEN AT THE APEX AND A SMALL PIECE OF WIRE TO BE CAUGHT IN THE INTERFACE BETWEEN THE PULLWIRE AND WIRE LOOP. A VISUAL EXAMINATION OF THE PULLWIRE FOUND IT TO BE THREADED THROUGH THE OTN SHEATH AND THE COATING WAS SLIGHTLY PEELED AT APEX. THE BROKEN ENDS OF WIRE LOOP WERE FRAYED. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE WIRE LOOP BROKE. DURING PLACEMENT THE PULLWIRE IS ATTACHED THROUGH THE FEEDING TUBE WIRE LOOP AND PULLED TIGHT. THE DEVICE IS THEN PULLED THROUGH THE STOMA BY APPLYING TENSILE FORCE TO THE PULLWIRE AND THE DELIVERY SYSTEM. BASED ON THE EVENT DESCRIPTION AND EVALUATION OF THIS AND OTHER RETURNED DEVICES WITH THE SAME ISSUE (WIRE LOOP BROKE), THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    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) FOR THE REPORTED EVENT OF LOOP WIRE ON END OF PEG TUBE BROKE. THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LOOP WIRE ON THE END OF THE PEG BROKE, OUTSIDE OF THE PATIENT, WHEN THE PEG WAS BEING PULLED OUT OF THE STOMA SITE. 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 ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LOOP WIRE ON THE END OF THE PEG BROKE, OUTSIDE OF THE PATIENT, WHEN THE PEG WAS BEING PULLED OUT OF THE STOMA SITE. 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
    50883 ENDOVIVE¿ SAFETY PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566521

    Patients

    Seq Age Sex Outcome Treatment
    1