BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 1931315 · Received December 17, 2010

    Report

    Report Number
    2134265-2010-05514
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 30, 2010
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF AN QUANTUM MAVERICK (MR) BALLOON CATHETER WITH NO OTHER DEVICES. IT WAS NOTED DURING UNPACKAGING THAT DRIED BLOOD AND CONTRAST WERE PRESENT IN THE SHAFT AND BALLOON. DUE TO THE DRIED BLOOD AND CONTRAST THE DEVICE WAS SOAKED FOR APPROXIMATELY 8 HOURS IN A BATH OF CIRCULATING 37°C WATER IN AN ATTEMPT TO LOOSEN AND DISLODGE DRIED MATERIAL FROM THE LUMEN OF THE DEVICE. THE DEVICE WAS PRESSURIZED WITH AN INFLATION DEVICE, WHICH CONFIRMED A BALLOON PINHOLE IN THE BALLOON WALL LOCATED 1.25 MM FROM THE DISTAL END OF PROXIMAL MARKERBAND. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. TIP DAMAGE WAS ALSO FOUND. THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS NOT COMPLEX. THE QUANTUM MAVERICK MONORAIL 8MM X 3.75MM BALLOON WAS INFLATED AND RUPTURED AT EIGHTEEN ATMOSPHERES. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS NOT COMPLEX. THE QUANTUM MAVERICK MONORAIL 8MM X 3.75MM BALLOON WAS INFLATED AND RUPTURED AT EIGHTEEN ATMOSPHERES. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808008370 13362597

    Patients

    Seq Age Sex Outcome Treatment
    1