BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1902284 · Received November 18, 2010

    Report

    Report Number
    3005099803-2010-04747
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE REVEALED THE SNARE LOOP TO BE RETRACTED INTO THE SHEATH. THE SHEATH OF THE DEVICE WAS MEASURED AND FOUND TO BE OUT OF SPECIFICATION. A FUNCTIONAL EVALUATION OF THE DEVICE WAS PERFORMED BY EXTENDING THE LOOP. UPON EXTENDING, THE LOOP WAS NOT EXPOSED FROM THE SHEATH. THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE SNARE WIRE WOULD NOT EXIT THE CATHETER. THIS WAS A KNOWN MANUFACTURING ISSUE IN WHICH THE SHEATH WAS INSUFFICIENTLY CUT DURING THE MANUFACTURING PROCESS. A CORRECTIVE ACTION HAS BEEN IMPLEMENTED. THIS DEVICE LOT WAS PRODUCED PRIOR TO THE IMPLEMENTATION OF THE CORRECTIVE ACTION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT 13393707 AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 13393707.

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF SNARE LOOP WIRE WOULD NOT EXTEND. 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 STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP WIRE WOULD NOT EXTEND FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A NEW BOSTON SCIENTIFIC SNARE. 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 STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP WIRE WOULD NOT EXTEND FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A NEW BOSTON SCIENTIFIC SNARE. 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 M00568201 13393707

    Patients

    Seq Age Sex Outcome Treatment
    1