BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2010892 · Received March 8, 2011

    Report

    Report Number
    2134265-2011-00708
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RECEIVED PRODUCT CONSISTED OF AN NC QUANTUM APEX BALLOON CATHETER. VISUAL AND MICROSCOPIC ANALYSIS REVEALED THE GUIDEWIRE USED IN THE PROCEDURE WAS NOT RETURNED WITH THE BALLOON CATHETER, A NEW APPROPRIATE SIZED GUIDEWIRE WAS INSERTED INTO THE LUMEN AND TRACKED OUT THE TIP. NO RESISTANCE WAS FOUND. USING A LASER MICROMETER, THE OUTER DIAMETER OF THE DEVICE MEASURED .03257", WHICH MEETS DEVICE SPECIFICATION. MICROSCOPIC INSPECTION REVEALED THE MIDSHAFT WAS DAMAGED, APPEARING TWISTED AND NO DAMAGE TO THE INNER WAS NOTED. 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 REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT CIRCUMFLEX ARTERY (LCX). THE 8MM X 2.75MM NC QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED AND INFLATED 18 TIMES. TO WHAT ATMS AND DURATION OF INFLATIONS IS UNKNOWN. DURING REMOVAL RESISTANCE WAS ENCOUNTERED AND THE BALLOON CATHETER COULD NOT BE REMOVED. AS A RESULT, THE BALLOON CATHETER AND A NON-BSC GUIDE WIRE WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT CIRCUMFLEX ARTERY (LCX). THE 8MM X 2.75MM NC QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED AND INFLATED 18 TIMES. TO WHAT ATMS AND DURATION OF INFLATIONS IS UNKNOWN. DURING REMOVAL RESISTANCE WAS ENCOUNTERED AND THE BALLOON CATHETER COULD NOT BE REMOVED. AS A RESULT, THE BALLOON CATHETER AND A NON-BSC GUIDE WIRE WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408270 13797371

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER, MACH1| GUIDE WIRE, SION BLUE