BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 3133274 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03690
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 2013
    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

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE QUANTUM MAVERICK CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL ON THE PROXIMAL END OF THE BALLOON. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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 PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. A 2.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE CALCIFIED UNSPECIFIED TARGET LESION FOR PRE-DILATION. THE BALLOON WAS INFLATED BUT IT RUPTURED ON THE FIRST INFLATION BEFORE THE PRESSURE REACHED TO RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE BALLOON CATHETER WAS REMOVED INTACT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. A 2.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE CALCIFIED UNSPECIFIED TARGET LESION FOR PRE-DILATION. THE BALLOON WAS INFLATED BUT IT RUPTURED ON THE FIRST INFLATION BEFORE THE PRESSURE REACHED TO RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE BALLOON CATHETER WAS REMOVED INTACT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236658 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808008200 15662369

    Patients

    Seq Age Sex Outcome Treatment
    1