BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMASH BALLOON DILATATION CATHETER

    MDR report key: 1030697 · Received April 15, 2008

    Report

    Report Number
    2134265-2008-01113
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 16, 2008
    Report Date
    March 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT #: 2134265-2008-01112. IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, INFLATION/DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE LESION WAS LOCATED IN THE LEFT FEMORAL ARTERY. THE HUB OF TWO 3.0MM X 80MM SMASH BALLOON DILATATION CATHETERS BROKE AND DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOONS WERE INFLATED ONCE TO 8 ATMS FOR 40 SECONDS. INFLATION DIFFICULTIES WERE ALSO REPORTED. OVER INFLATION OF THE BALLOONS WAS PERFORMED TO SUCCESSFULLY DEFLATE THE BALLOONS FOR REMOVAL. BOTH BALLOONS WERE REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS "GOOD / POSITIVE". MULTIPLE ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMASH BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA 0009657656

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR