BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 1950701 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05866
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE MONORAIL (MR) NC QUANTUM APEX BALLOON CATHETER WAS RETURNED FOR ANALYSIS; HOWEVER, THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS. MAGNIFIED AND TACTILE ANALYSIS REVEALED MULTIPLE KINKS IN THE HYPOTUBE. THE INNER DIAMETER OF THE TIP AND WIRE EXIT NOTCH WERE WITHIN SPECIFICATIONS. A NEW .014" GUIDE WIRE WAS ADVANCED ALL THE WAY THROUGH THE WIRE LUMEN WITH NO RESISTANCE ENCOUNTERED. DESPITE A THOROUGH ANALYSIS OF THE RETURNED DEVICE, IT WAS NOT POSSIBLE TO VERIFY THE REPORTED TRACKING DIFFICULTY. 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, THE CATHETER STUCK ON THE GUIDE WIRE. VASCULAR ACCESS WAS OBTAINED VIA THE GROIN. THE 90% STENOSED DE NOVO LESION WAS LOCATED IN THE MILDLY TORTUOUS, NON CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION WAS PREDILATED WITH A 3.0X12 APEX BALLOON CATHETER, AND A PROMUS 3.5X15 STENT WAS SUCCESSFULLY IMPLANTED. A 8MM X 4.50MM NC QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED AND INFLATED TO 16 ATMS TO POST DILATE THE STENT. THE BALLOON WAS FULLY DEFLATED AND FRICTION WAS EXPERIENCED DURING WITHDRAWAL. THE BALLOON AND A NON-BSC GUIDE WIRE BECAME STUCK TOGETHER DURING WITHDRAWAL. THE NON-BSC GUIDE WIRE AND THE BALLOON CATHETER WERE SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE CATHETER STUCK ON THE GUIDE WIRE. VASCULAR ACCESS WAS OBTAINED VIA THE GROIN. THE 90% STENOSED DE NOVO LESION WAS LOCATED IN THE MILDLY TORTUOUS, NON CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION WAS PREDILATED WITH A 3.0X12 APEX BALLOON CATHETER, AND A PROMUS 3.5X15 STENT WAS SUCCESSFULLY IMPLANTED. A 8MM X 4.50MM NC QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED AND INFLATED TO 16 ATMS TO POST DILATE THE STENT. THE BALLOON WAS FULLY DEFLATED AND FRICTION WAS EXPERIENCED DURING WITHDRAWAL. THE BALLOON AND A NON-BSC GUIDE WIRE BECAME STUCK TOGETHER DURING WITHDRAWAL. THE NON-BSC GUIDE WIRE AND THE BALLOON CATHETER WERE SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    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 H7493912408450 13847518

    Patients

    Seq Age Sex Outcome Treatment
    1 41 DA STENT, PROMUS 3.5X15| BALLOON CATHETER, APEX 3.0X12| GUIDE WIRE, PROWATER