BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 1831309 · Received September 10, 2010

    Report

    Report Number
    2134265-2010-03938
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER IN TWO PIECES WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THE FIRST PIECE MEASURED APPROXIMATELY 85 CM FROM THE END OF THE STRAIN RELIEF TO THE HYPOTUBE FRACTURE SITE. THE SECOND PIECE MEASURED APPROXIMATELY 56.5 CM FROM THE HYPOTUBE FRACTURE SITE TO THE TIP. THE APPEARANCE OF THE FRACTURE SURFACE IS CONSISTENT WITH THE DEVICE BEING KINKED PRIOR TO THE BREAK. INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED 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).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PURPOSE OF THE QUANTUM MAVERICK 2.25X12MM BALLOON WAS POST DILATION. IT HAD ONLY BEEN ADVANCED ONE TIME AND WAS INFLATED ONCE AT 16ATM FOR 10 SECONDS. THE SITE ORIGINALLY REPORTED RESISTANCE WITHDRAWING THE DEVICE. ADDITIONAL INFORMATION STATES THAT THERE WAS NO RESISTANCE ADVANCING OR WITHDRAWING THE BALLOON. ALL OF THE PIECES OF THE DEVICE WERE REMOVED SUCCESSFULLY FROM THE PATIENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PURPOSE OF THE QUANTUM MAVERICK 2.25X12MM BALLOON WAS POST DILATION. IT HAD ONLY BEEN ADVANCED ONE TIME AND WAS INFLATED ONCE AT 16ATM FOR 10 SECONDS. THE SITE ORIGINALLY REPORTED RESISTANCE WITHDRAWING THE DEVICE. ADDITIONAL INFORMATION STATES THAT THERE WAS NO RESISTANCE ADVANCING OR WITHDRAWING THE BALLOON. ALL OF THE PIECES OF THE DEVICE WERE REMOVED SUCCESSFULLY FROM THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. ACCESS WAS GAINED VIA THE RADIAL ARTERY. THE 90% STENOSED, CONCENTRIC AND 20MM LONG DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. IT WAS REPORTED THAT THERE WAS SIGNIFICANT LESION BEND BETWEEN 45 AND 90 DEGREES. THE PHYSICIAN USED AN UNSPECIFIED STENT BALLOON AND THE 2.25X12MM QUANTUM MAVERICK BALLOON IN A KISSING TECHNIQUE. DURING WITHDRAWAL, RESISTANCE WAS ENCOUNTERED AND THE SHAFT OF THE QUANTUM MAVERICK WAS BROKEN. THE BROKEN PIECE WAS INSIDE THE GUIDE CATHETER. THE GUIDE CATHETER WAS REMOVED TOGETHER WITH THE QUANTUM MAVERICK BALLOON AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    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 H7493808012220 13370198

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR