BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION¿ SHORT THROW

    MDR report key: 2896897 · Received January 4, 2013

    Report

    Report Number
    3005099803-2013-00045
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT: HANDLE CANNULA BROKEN. 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

    VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THAT THE HANDLE CANNULA AND PEEK TUBING WERE BENT, AND THE STRAIN RELIEF WAS VISIBLY CURVED. SEVERAL BENDS WERE NOTED IN THE SHEATH. ADDITIONALLY, IT WAS OBSERVED THAT THE FINGER RING ASSEMBLY HAD DEFLECTED OUT OF THE HANDLE BODY ("DISMOUNTED"). THE COMPLAINT WAS CONFIRMED, AS THE AUDIBLE CRACK HEARD BY THE PHYSICIAN WAS LIKELY THE DEFLECTION OF THE FINGER RING ASSEMBLY. WHEN THE STRAIN RELIEF IS CURVED, THE HANDLE CANNULA CONTACTS THE INNER SHEATH DURING EXTENSION AND CAN ULTIMATELY BEND DUE TO RESISTANCE. THE BENDING OF THE HANDLE CANNULA CAN SUBSEQUENTLY PUSH THE FINGER RING ASSEMBLY OUT OF THE HANDLE BODY, PRODUCING THE FAILURE FOUND. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL SNARE WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS CLOSING THE SNARE AROUND THE POLYP, A LOUD CRACK WAS HEARD. IT WAS SUSPECTED THAT THE HANDLE CANNULA HAD BROKEN. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE "OK."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL SNARE WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS CLOSING THE SNARE AROUND THE POLYP, A LOUD CRACK WAS HEARD. IT WAS SUSPECTED THAT THE HANDLE CANNULA HAD BROKEN. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE "OK." PRODUCT ANALYSIS REVEALED THE HANDLE CANNULA AND SHEATH WERE BENT, AND THE FINGER RING ASSEMBLY HAD DEFLECTED OUT OF THE HANDLE BODY ("DISMOUNTED"). THE HANDLE CANNULA WAS NOT BROKEN; THEREFORE, THIS IS NO LONGER AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4563 SENSATION¿ SHORT THROW MEDIUM OVAL - FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562673 15225369

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR