BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE¿ SAFETY PEG KIT

    MDR report key: 2914753 · Received January 14, 2013

    Report

    Report Number
    3005099803-2012-06437
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED LOT NUMBER 15618889 MATCHES TWO DIFFERENT TOP ASSEMBLY LOT NUMBERS 15739809 AND 15739811 FOR THIS UPN (B)(4). THIS CUSTOMER HAS RECEIVED BOTH LOT NUMBERS; THEREFORE, IT CANNOT BE DETERMINED WHICH LOT NUMBER WAS USED. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) FOR THE REPORTED EVENT OF SNARE BREAK. THE DEVICE HAS NOT 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.

    Additional Manufacturer Narrative · 1

    MEDICAL CENTER (B)(6) SUBMITTED MEDWATCH REPORT #: (B)(4) IN (B)(6) 2012.

    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 PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PULLWIRE THAT RUNS THROUGH THE PLASTIC OUTER SHEATH DETACHED FROM THE PULL HANDLE WITH AN AUDIBLE SNAP. ONCE THE WIRE WAS BROKEN, CONTROL OF THE LOOPED END WAS LOST AND BLUE PULLWIRE USED TO PULL THE PEG THROUGH THE PATIENT WAS RELEASED. THE BROKEN SNARE WAS REMOVED FROM THE GASTROSCOPE AND A NEW SNARE WAS USED TO RETRIEVE THE BLUE PULL GUIDEWIRE SUCCESSFULLY. 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 A ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PULLWIRE THAT RUNS THROUGH THE PLASTIC OUTER SHEATH DETACHED FROM THE PULL HANDLE WITH AN AUDIBLE SNAP. ONCE THE WIRE WAS BROKEN, CONTROL OF THE LOOPED END WAS LOST AND BLUE PULLWIRE USED TO PULL THE PEG THROUGH THE PATIENT WAS RELEASED. THE BROKEN SNARE WAS REMOVED FROM THE GASTROSCOPE AND A NEW SNARE WAS USED TO RETRIEVE THE BLUE PULL GUIDEWIRE SUCCESSFULLY. 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
    20970 ENDOVIVE¿ SAFETY PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566481 15739809

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other