BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 1885085 · Received October 28, 2010

    Report

    Report Number
    2134265-2010-05008
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX CATHETER WITH NO ORIGINAL PACKAGING WITH A KINETIX GUIDEWIRE. THE RETURNED KINETIX GUIDEWIRE WAS TRACKED THROUGH THE WIRE LUMEN OF THE CATHETER WITHOUT ANY DIFFICULTIES. VISUAL AND MICROSCOPIC INSPECTION REVEALED NO DAMAGE OR IRREGULARITIES REGARDING THE CATHETER. PRODUCT ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. 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

    SAME CASE AS MFR # 2134265-2010-04889, 2134265-2010-05009. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, WITHDRAWAL RESISTANCE OCCURRED. THE 80-85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A KINETIX GUIDEWIRE WAS PLACED IN THE LESION AND THEN A 2.75X20MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND SUCCESSFULLY DEPLOYED. WHILE REMOVING THE SDS OVER THE WIRE IT WAS NOTED THAT SYSTEMS BECAME ''GUMMY'' AND THE PHYSICIAN EXPERIENCED DIFFICULTY WITHDRAWING THE SDS. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THEN A 3.0X8MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED OVER THE KINETIX GUIDEWIRE FOR POST DILATION. AFTER INFLATION OF THE BALLOON, THE BALLOON CATHETER AND GUIDEWIRE WERE REMOVED FROM THE PATIENT AS A SYSTEM. ONCE OUTSIDE THE PATIENT, THE PHYSICIAN FELT RESISTANCE WHILE TRYING TO REMOVE THE BALLOON CATHETER FROM THE WIRE; HOWEVER, THE DEVICES WERE ABLE TO BE SEPARATED. IT WAS NOTED THAT THE PHYSICIAN FELT RESISTANCE ON THE LAST 100CM OF THE GUIDEWIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION IS OKAY.

    Description of Event or Problem · 1

    SAME CASE AS MFR # 2134265-2010-04889, 2134265-2010-05009. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE WITHDRAWAL RESISTANCE OCCURRED. THE 80-85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A KINETIX GUIDEWIRE WAS PLACED IN THE LESION AND THEN A 2.75X20MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND SUCCESSFULLY DEPLOYED. WHILE REMOVING THE SDS OVER THE WIRE IT WAS NOTED THAT SYSTEMS BECAME "GUMMY" AND THE PHYSICIAN EXPERIENCED DIFFICULTY WITHDRAWING THE SDS. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THEN A 3.0X8MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED OVER THE KINETIX GUIDEWIRE FOR POST DILATION. AFTER INFLATION OF THE BALLOON, THE BALLOON CATHETER AND GUIDEWIRE WERE REMOVED FROM THE PATIENT AS A SYSTEM. ONCE OUTSIDE THE PATIENT, THE PHYSICIAN FELT RESISTANCE WHILE TRYING TO REMOVE THE BALLOON CATHETER FROM THE WIRE; HOWEVER, THE DEVICES WERE ABLE TO BE SEPARATED. IT WAS NOTED THAT THE PHYSICIAN FELT RESISTANCE ON THE LAST 100CM OF THE GUIDEWIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION IS OKAY.

    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 H7493912508300 13664849

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR KINETIX GUIDEWIRE| MACH 1 GUIDE CATHETER| 2.75X20MM TAXUS LIBERTE STENT