BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 1871360 · Received October 15, 2010

    Report

    Report Number
    2134265-2010-04548
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 25, 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

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH NO OTHER DEVICES. ONLY THE PROXIMAL END OF THE DEVICE WAS RETURNED. THE PROXIMAL END OF THE HYPOTUBE MEASURED 87CM FROM THE EDGE OF THE MANIFOLD TO WHERE THE FRACTURE WAS LOCATED. NO OTHER DAMAGE TO THE DEVICE COULD BE VERIFIED AS THE DISTAL SHAFT WITH BALLOON WAS NOT RETURNED. 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

    (B)(4)

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DISTAL END OF THE DEVICE WAS NOT LEFT INSIDE THE PATIENT AND MOST LIKELY WAS MISTAKENLY NOT RETURNED BY THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A SHAFT BREAK OCCURRED. THE INDICATION FOR PROCEDURE WAS ANGINA PECTORIS. VASCULAR ACCESS WAS OBTAINED THROUGH THE RIGHT RADIAL ARTERY. THE PHYSICIAN WAS TREATING AN 80% STENOSED, ECCENTRIC SHAPED, 11MM LONG, DE-NOVO LESION LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED, 3.5MM IN DIAMETER, DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH A 2.5X15MM MAVERICK 2 BALLOON CATHETER RESULTING IN 50% RESIDUAL STENOSIS. ANOTHER MANUFACTURERS' 3.5X15MM STENT WAS IMPLANTED IN THE LESION. THE PHYSICIAN WANTED TO USE THIS 3.5X12MM QUANTUM MAVERICK BALLOON CATHETER TO POST-DILATE, HOWEVER, THE SHAFT BROKE WHILE ADVANCING. THE BROKEN SECTION WAS LOCATED OUTSIDE THE PATIENT. POST-DILATION WAS COMPLETED WITH ANOTHER MANUFACTURERS' 3.5X12MM BALLOON CATHETER. 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 H7493808012350 0013271280

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR GUIDE CATHETER: LAUNCHER 6F EBU3.5| BALLOON CATHETER: 3.5X12MM NC VOYAGER| BALLOON CATHETER: 2.5X15MM MAVERICK2| STENT: 3.5X15MM XIENCE V| GUIDE WIRE: BMW 190