BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR¿

    MDR report key: 3103268 · Received May 9, 2013

    Report

    Report Number
    3005099803-2013-03341
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 6, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATED RESULT: SHEATH TORN/SPLIT. INVESTIGATION RESULTS VISUAL EVALUATION OF THE COMPLAINT DEVICE REVEALED THAT THE CATHETER WAS CRUSHED, TORN/SPLIT, AND THE WIRE WAS PROTRUDING OUT OF THE CATHETER NEAR THE HANDLE. THE CATHETER LENGTH WAS MEASURED AND WAS WITHIN MANUFACTURING SPECIFICATION. A FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE DAMAGE OF THE CATHETER. THE COMPLAINT WAS NOT CONFIRMED, THE WORKING LENGTH WAS WITHIN SPECIFICATIONS. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THIS COMPLAINT AS IT IS MOST LIKELY THAT THE COMPLAINT WAS CAUSED BY HANDLING OF THE DEVICE DURING PROCEDURE OUTSIDE THE PATIENT. 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 CAPTIVATOR MEDIUM OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE SNARE OVEREXTENDED WHEN IT WAS TESTED OUTSIDE THE PATIENT. IT WAS REPORTED THAT THE LOOP COULD NOT BE FULLY RETRACTED DUE TO THE OVEREXTENSION. ANOTHER CAPTIVATOR SNARE WAS USED TO COMPLETE THE PROCEDURE. 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. PRODUCT ANALYSIS REVEALED THE WORKING LENGTH TO BE TORN/SPLIT; THEREFORE, THIS IS NOW A MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203462 CAPTIVATOR¿ MEDIUM OVAL - STIFF FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562321 15549232

    Patients

    Seq Age Sex Outcome Treatment
    1