BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2093414 · Received May 18, 2011

    Report

    Report Number
    2134265-2011-01870
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT ANALYSIS REVEALED BLOOD AND CONTRAST IN THE HUB AND WIRE LUMEN. INSPECTION OF THE BALLOON REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL MATERIAL ON THE DISTAL END OF THE BALLOON MEASURING 6MM LONG. MICROSCOPIC INSPECTION OF THE BALLOON MATERIAL AND THE REMAINDER OF THE DEVICE REVEALED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGED BALLOON. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY. A NON BSC 2.5MM BALLOON CATHETER WAS ADVANCED TO THE LESION AND DURING AN UNSPECIFIED INFLATION ATTEMPT, THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE. THE 2.5X8.0MM NC QUANTUM APEX BALLOON CATHETER WAS THEN ADVANCED TO THE LESION FOR PRE-DILATION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 12ATMS. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. IT WAS FURTHER NOTED THAT THE PHYSICIAN THOUGHT THE BALLOON MAY HAVE RUPTURED DUE TO THE SEVERE CALCIFICATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408250 13750585

    Patients

    Seq Age Sex Outcome Treatment
    1 2.5MM NC MERCURY BALLOON CATHETER