BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1489280 · Received July 28, 2009

    Report

    Report Number
    2134265-2009-03502
    Event Type
    Malfunction
    Date Received
    July 28, 2009
    Date of Event
    July 1, 2009
    Report Date
    July 1, 2009
    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

    PRODUCT ANALYSIS VERIFIED THE SHAFT DETACHED/SEPARATED FOR THIS COMPLAINT. THE QUANTUM MAVERICK BALLOON DEVICE WAS RECEIVED IN 2 PIECES. THE FIRST PIECE WAS MEASURED FROM THE DISTAL EDGE OF THE STRAIN RELIEF TO THE SHAFT DETACHED/SEPARATED LOCATION AND MEASURED 112 CENTIMETERS. THE SECOND PIECE WAS MEASURED FROM THE SHAFT DETACHED/SEPARATED LOCATION TO THE DISTAL END OF THE TIP MEASURED 55 CENTIMETERS. THE MIDSHAFT APPEARED TO BE STRETCHED/ELONGATED, INDICATING THAT TENSILE FORCE WAS APPLIED TO THE DEVICE. THERE WAS NO OTHER DAMAGE OR ABNORMALITIES FOUND. 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 A PERCUTANEOUS CORONARY INTERVENTION (PCI), A CATHETER SHAFT BREAK OCCURRED. THE PROCEDURE WAS INDICATED DUE TO ANGINA PECTORIS (AP). THE TARGET LESION WAS LOCATED IN THE ANASTAMOSIS OF THE SAPHENOUS VEIN GRAFT (SVG) TO THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE TARGET LESION WAS PREDILATED WITH A 3.0-10MM NON-BSC BALLOON CATHETER TO 10 ATMS TWICE. A 4.0X12MM NON-BSC STENT WAS IMPLANTED TO TREAT THE TARGET LESION. A QUANTUM MAV MON 12MM X 5.0MM BALLOON CATHETER WAS ADVANCED POST-STENTING AND INFLATED ONCE TO 12 ATMS AND ONCE TO 20 ATMS. THE PHYSICIAN THEN DECIDED TO PERFORM KISSING BALLOON TECHNIQUE (KBT) BETWEEN THE SGV AND LAD. THE QUANTUM MAV MON 12MM X 5.0MM REMAINED IN THE TARGET LESION WHILE A 2.5-10MM NON-BSC BALLOON CATHETER WAS INSERTED. DURING INSERTION OF THE NON-BSC BALLOON, "SEVERE FRICTION" WAS ENCOUNTERED AND THE PHYSICIAN DECIDED NOT TO FURTHER PURSUE KBT. THE NON-BSC BALLOON CATHETER WAS REMOVED. THE PHYSICIAN ATTEMPTED TO REMOVE THE QUANTUM MAVERICK AND ENCOUNTERED "SEVERE RESISTANCE" IN THE LESION WHERE THE NON-BSC STENT WAS IMPLANTED. ALTHOUGH THE PHYSICIAN CONTINUED TO EXPERIENCE "SEVERE" RESISTANCE, THE QUANTUM MAVERICK WAS ABLE TO BE WITHDRAWN INTO THE 6F MACH1 A1 GUIDE CATHETER. "SUDDENLY", THE RESISTANCE DISAPPEARED, AND IT WAS NOTICED THAT ONLY THE PROXIMAL PORTION OF THE DEVICE WAS REMOVED. THE REMAINDER OF THE BALLOON CATHETER WAS LOCATED IN THE GUIDE CATHETER AND WAS ABLE TO BE REMOVED FROM THE PATIENT. THERE WAS NO PATIENT 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 12X5.0 MM 11735835

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSEND LACROSSE 2.5-10MM| DRIVER STENT 4.0-12MM| 6F MACH1 A1| KONGO 3.0-10MM