BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1190564 · Received October 6, 2008

    Report

    Report Number
    2134265-2008-02916
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    July 29, 2008
    Report Date
    September 9, 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

    PROD ANALYSIS CONFIRMED THE DIFFICULTY STATED IN THE COMPLAINT. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED A BROKEN SHAFT. THE CATHETER WAS RETURNED IN TWO PIECES WITHOUT THE CARRIER TUBE. THE BREAK OCCURRED 17 CM FROM THE DISTAL EDGE OF THE STRAIN RELIEF. THERE WAS NO NECKING OR STRETCHING AT THE FAILURE SITE SUGGESTING THAT THE DEVICE PASSED TENSILE TEST. A REVIEW OF THE MFG RECORDS FOR THIS BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PROD SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS ATTRIBUTED OPERATIONAL CONTEXT DUE TO THE ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A SHAFT BREAK OCCURRED. THE 90% STENOTIC AND CALCIFIED LESION WAS LOCATED IN THE EXTREMELY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. UPON ATTEMPT TO ADVANCE THE QUANTUM MAVERICK 12MM X 2.75MM BALLOON CATHETER ACROSS A SIDE BRANCH FOR POST-DILATATION OF A TAXUS STENT, SIGNIFICANT RESISTANCE WAS ENCOUNTERED AND THE SHAFT FRACTURE AT THE Y-CONNECTOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE. THERE WERE NO PT INJURIES OR COMPLICATIONS. THE PT'S STATUS WAS REPORTED AS "GOOD." HOWEVER, THE RETURNED PROD REVEALED A FRACTURE 17CM FROM THE STRAIN RELIEF.

    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 12X2.75 MM 11302775

    Patients

    Seq Age Sex Outcome Treatment
    1