BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1220286 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04196
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: PRODUCT ANALYSIS COULD NOT CONFIRM THE COMPLAINT. THE BALLOON WAS RETURNED IN AN INFLATED STATE WITH CONTRAST AND BLOOD PRESENT IN THE BALLOON AND DISTAL OUTER. THE RETURNED CATHETER EXHIBITED DAMAGE TO THE DISTAL OUTER AND THE INNER LOCATED .05 CENTIMETERS PROXIMALLY FROM THE BALLOON WRIST. THE DISTAL OUTER AND INNER WERE ACCORDIANED. THE RETURNED CATHETER ALSO EXHIBITED DAMAGE TO THE DISTAL TIP. THE BALLOON WAS PRESSURIZED TO NOMINAL BURST PRESSURE BUT BALLOON WOULD NOT INFLATE BECAUSE OF THE SHAFT DAMAGE, SO A NEGATIVE PRESSURE WAS PULLED AND THE BALLOON DID NOT DEFLATE. IT WAS NOT POSSIBLE TO DETERMINE HOW OR WHEN THE DAMAGE OCCURRED. THE MANUFACTURING RECORDS HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT IS DETERMINED TO BE OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), THE BALLOON WAS NOT FULLY DEFLATED. THE 99% STENOSED, SEVERELY CALCIFIED TARGET LESION WAS IN THE SEVERELY TORTUOUS LEFT MAIN (LM) CORONARY ARTERY EXTENDING TO THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A NON-BSC GUIDE CATHETER AND GUIDE WIRE WERE INSERTED. THE LESION WAS PRETREATED WITH A 1.5 MM AND 1.75 MM ROTABLATOR BURRS. THE LESION WAS PREDILATED WITH A 3.5X15 MM MAVERICK2 BALLOON CATHETER. A 3.5X18 MM NON-BSC DRUG ELUTING STENT (DES) WAS IMPLANTED. THE LESION WAS POST DILATED WITH A 3.5X15 MM QUANTUM MAVERICK BALLOON CATHETER. THE QUANTUM MAVERICK BALLOON WAS INFLATED TO 10 ATMOSPHERES FOR 15 SECONDS. THE DEVICE WAS REMOVED WITHOUT RESISTANCE. OUTSIDE THE PT'S BODY, IT WAS NOTICED THAT THE BALLOON APPEARED PARTIALLY DEFLATED WITH APPROXIMATELY 1/4 CONTRAST MATERIAL STILL IN THE BALLOON. THE PREVIOUSLY IMPLANTED NON-BSC DES WAS POST DILATED WITH A 3.0X15 MM NON-BSC BALLOON CATHETER. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 15X3.5 MM 11530586

    Patients

    Seq Age Sex Outcome Treatment
    1 3.0X15MM RYUJIN BALLOON CATHETER| RUNTHROUGH GUIDEWIRE| 3.5X18MM CYPHER STENT| BRITE-TIP 7F JL4SH GUIDE CATHETER