BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1063640 · Received June 19, 2008

    Report

    Report Number
    2134265-2008-01737
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS CONFIRMED THE DIFFICULTY STATED IN THE COMPLAINT. THE BALLOON CATHETER WAS RETURNED IN A DEFLATED STATE. BLOOD WAS OBSERVED IN THE BALLOON AND INFLATION LUMEN. MICROSCOPIC INSPECTION FOUND A PINHOLE LOCATED OVER THE PROXIMAL MARKERBAND. MICROSCOPIC EXAMINATION OF THE AREA SURROUNDING THE PINHOLE DID NOT REVEAL ANY IRREGULARITIES IN THE BALLOON MATERIAL WHICH WOULD HAVE CONTRIBUTED TO THE PINHOLE. THE MOST PROBABLE ROOT CAUSE IS DETERMINED TO BE OPERATIONAL CONTEXT, DUE TO THE LIKELIHOOD OF ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, WHICH CONTRIBUTED TO THE REPORTED EVENT. IT SHOULD BE NOTED THAT THERE WAS NO EVIDENCE OF MANUFACTURING DEFECT OR ANOMALY WITHIN THE MANUFACTURING RECORDS REVIEWED FOR THE REPORTED BATCH.

    Description of Event or Problem · 1

    EVENT BECAME REPORTABLE BASED UPON ANALYSIS COMPLETED 05/20/2008. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON LEAK OCCURRED. THE SERIOUSLY CALCIFIED 80% STENOTIC LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED WITH A 2.5 X 15MM UNSPECIFIED BALLOON. AFTER THE PHYSICIAN DEPLOYED AN UNSPECIFIED STENT, THE 3.25 X 15MM QUANTUM MAVERICK BALLOON WAS USED FOR POST-DILATION; AT 18 ATMOSPHERES OF PRESSURE THE BALLOON LEAKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETER, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 15 X 3.25 MM 11404754

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR