BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2993101 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01229
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    December 6, 2012
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION OF THE DEVICE REVEALED STAIN ON THE BARREL OF THE DEVICE. THE DEVICE WAS DISMANTLED AND IT WAS NOTED THE STAIN WAS ON THE INSIDE OF THE BARREL, AND BOTH THE CLEAR AND BLUE HOUSINGS. THE STAINS WERE WIPED WITH ALCOHOL TO REMOVE THE STAIN. THE COLOR OF THE STAIN WAS REMOVED BUT THE SURFACES WERE LEFT ROUGH. FUNCTIONAL TESTING PERFORMED REVEALED NO ANOMALIES WITH THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE THERE WAS A STAIN INSIDE OF THE DEVICE. IT WAS NOTED THAT INSIDE OF THE CHAMBER OF THE ADVANTAGE 26 INFLATION UNIT IT APPEARED THAT THERE WAS A STAIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE THERE WAS A STAIN INSIDE OF THE DEVICE. IT WAS NOTED THAT INSIDE OF THE CHAMBER OF THE ADVANTAGE 26 INFLATION UNIT IT APPEARED THAT THERE WAS A STAIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97363 ADVANTAGE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904527011 15599344

    Patients

    Seq Age Sex Outcome Treatment
    1