BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1982786 · Received February 9, 2011

    Report

    Report Number
    3005099803-2011-00180
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: ROOT CAUSE - MANUFACTURING - TO HEIGHTEN OPERATOR AWARENESS, THE WORK CENTER OPERATORS WERE INFORMED OF THE NON-CONFORMITY. THE OPERATORS INVOLVED WERE THEN RETRAINED TO THE STANDARD OPERATING PROCEDURES.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE REVEALED THE SNARE LOOP TO HAVE DETACHED FROM THE DISTAL END OF THE SNARE CABLE. THE LOOP WAS BENT AND OUT OF SHAPE. THE SHEATH WAS REMOVED TO ALLOW EXAMINATION OF THE CABLE DISTAL END. THE CABLE DISTAL END DID NOT PRESENT ANY DEFECTS. AN EXAMINATION OF THE LOOP CONNECTOR COUPLING REVEALED THE COUPLING TO BE SECURELY CRIMPED TO THE LOOP ENDS. THE CRIMPS FOR THE CABLE WERE FULLY FORMED. THE CRIMPS ON THE CONNECTOR COUPLING FROM CENTER OF LOOP CRIMP TO CENTER OF CABLE CRIMP WERE MEASURED AND WERE FOUND TO BE OUT OF SPECIFICATION. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE SNARE LOOP DETACHED. PHYSICAL EXAMINATION OF THE DEVICE REVEALED THE DISTANCE BETWEEN THE CONNECTOR COUPLING CRIMPS TO BE OUT OF SPECIFICATION. BECAUSE THE CABLE CRIMP WAS PLACED TOO CLOSE TO THE LOOP CRIMP, THE END OF THE CABLE WAS NOT SECURELY CAPTURED BY THE CRIMP AND ALLOWED THE CABLE TO SLIDE OUT OF THE COUPLING DURING USE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 14018537 WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 14018537.

    Additional Manufacturer Narrative · 1

    (B)(4) - RETRIEVAL OF DEVICE FRAGMENT. (B)(4) - THE REPORTED EVENT OF LOOP ON THE SNARE DETACHED. 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 AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE PULLING THE PEG TUBE THROUGH THE PATIENT'S MOUTH, THE LOOP ON THE SNARE BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN RETRIEVED THE BROKEN LOOP USING BIOPSY FORCEPS. A NEW SNARE FROM THE HOSPITAL'S STOCK WAS USED. THIS ENDOVIVE STANDARD PEG KIT PULL METHOD DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE PULLING THE PEG TUBE THROUGH THE PATIENT'S MOUTH, THE LOOP ON THE SNARE BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN RETRIEVED THE BROKEN LOOP USING BIOPSY FORCEPS. A NEW SNARE FROM THE HOSPITAL'S STOCK WAS USED. THIS ENDOVIVE STANDARD PEG KIT PULL METHOD DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE PULLING THE PEG TUBE THROUGH THE PATIENT'S MOUTH, THE LOOP ON THE SNARE BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN RETRIEVED THE BROKEN LOOP USING BIOPSY FORCEPS. A NEW SNARE FROM THE HOSPITAL'S STOCK WAS USED. THIS ENDOVIVE STANDARD PEG KIT PULL METHOD DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 14018537

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other