BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX?

    MDR report key: 3132400 · Received May 29, 2013

    Report

    Report Number
    3005099803-2013-04235
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: INCOMPLETE SEAL. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2013-04234 ADDRESSES THE FIRST CAPTIFLEX SNARE, WHILE MANUFACTURER REPORT #3005099803-2013-04235 ADDRESSED THE SECOND CAPTIFLEX SNARE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2013 THAT TWO CAPTIFLEX SMALL OVAL SNARES WERE UNPACKED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING UNPACKING OF THE DEVICES, IT WAS NOTED THAT THE POUCHES WERE NOT COMPLETELY SEALED; APPROXIMATELY ONE INCH OF THE CLEAR PLASTIC HAD SEPARATED FROM THE WHITE PLASTIC. A THIRD CAPTIFLEX 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2013-04234 ADDRESSES THE FIRST CAPTIFLEX SNARE, WHILE MANUFACTURER REPORT #3005099803-2013-04235 ADDRESSED THE SECOND CAPTIFLEX SNARE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT TWO CAPTIFLEX SMALL OVAL SNARES WERE UNPACKED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING UNPACKING OF THE DEVICES, IT WAS NOTED THAT THE POUCHES WERE NOT COMPLETELY SEALED; APPROXIMATELY ONE INCH OF THE CLEAR PLASTIC HAD SEPARATED FROM THE WHITE PLASTIC. A THIRD CAPTIFLEX 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2013-04234 ADDRESSES THE FIRST CAPTIFLEX SNARE, WHILE MANUFACTURER REPORT #3005099803-2013-04235 ADDRESSED THE SECOND CAPTIFLEX SNARE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT TWO CAPTIFLEX SMALL OVAL SNARES WERE UNPACKED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING UNPACKING OF THE DEVICES, IT WAS NOTED THAT THE POUCHES WERE NOT COMPLETELY SEALED; APPROXIMATELY ONE INCH OF THE CLEAR PLASTIC HAD SEPARATED FROM THE WHITE PLASTIC. A THIRD CAPTIFLEX 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236879 CAPTIFLEX? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562422 15686238

    Patients

    Seq Age Sex Outcome Treatment
    1