BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSBOSS CATHETER

    MDR report key: 3922755 · Received July 9, 2014

    Report

    Report Number
    2134265-2014-03862
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K102725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THERE WAS CONTRAST ON THE SHAFT OF THE DEVICE. TACTILE AND VISUAL INSPECTION WITH MAGNIFICATION REVEALED NO DAMAGE OR IRREGULARITIES. FUNCTIONAL TESTING WAS PERFORMED BY FLUSHING THE LUMEN WITH TAP WATER USING A 5MM SYRINGE. WHEN FLUSHED, A MAJORITY OF THE WATER FLOWED FROM THE DISTAL TIP BUT WATER ALSO LEAKED FROM THE JUNCTION OF THE HYTREL AND POLYURETHANE SHAFT SEGMENTS. THE GAP AT THE HYTREL-POLYURETHANE JUNCTION WAS MEASURED WITH A CALIBRATED STEEL RULE; THE GAP MEASURED WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THEY NOTICED A WHOLE IN THE CATHETER. THE USER OPENED UP THE BOX, PULLED THIS CROSSBOSS CATHETER OUT AND WHEN ATTEMPTING TO PREP IT, THEY NOTICED THAT THERE WAS A HOLE IN THE CATHETER LINING. IT WAS NOTED THAT THEY DID NOT USE THIS DEVICE AND THEY NEVER PUT IT IN THE PATIENT. THEY SET IT ASIDE AND GRABBED A NEW ONE OUT OF A DIFFERENT BOX. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THEY NOTICED A WHOLE IN THE CATHETER. THE USER OPENED UP THE BOX, PULLED THIS CROSSBOSS CATHETER OUT AND WHEN ATTEMPTING TO PREP IT, THEY NOTICED THAT THERE WAS A HOLE IN THE CATHETER LINING. IT WAS NOTED THAT THEY DID NOT USE THIS DEVICE AND THEY NEVER PUT IT IN THE PATIENT. THEY SET IT ASIDE AND GRABBED A NEW ONE OUT OF A DIFFERENT BOX. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401295 CROSSBOSS CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H749M2000A0 B132890180

    Patients

    Seq Age Sex Outcome Treatment
    1