BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 1999455 · Received February 23, 2011

    Report

    Report Number
    2134265-2011-00273
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A QUANTUM APEX BALLOON CATHETER WAS RECEIVED IN TWO PIECES WITH AND AN UNKNOWN GUIDEWIRE. VISUAL AND MICROSCOPIC ANALYSIS REVEALED THE BALLOON CATHETER WAS RECEIVED FRACTURED .05CM DISTALLY FROM THE GUIDEWIRE EXIT NOTCH. MICROSCOPIC INSPECTION REVEALED THE SHAFT WAS STRETCHED NEAR THE FRACTURE SITE. THE FRACTURE SURFACE MATERIAL APPEARS JAGGED AND STRETCHED WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). 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 PROCEDURE A SHAFT FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED DENOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A NC QUANTUM APEX MR 15MM X 3.50MM BALLOON CATHETER WAS INFLATED ONCE TO 6 ATMS TO PRE DILATE THE LESION. A PROMUS STENT WAS IMPLANTED. AN UNKNOWN SIZED NON-BSC BALLOON WAS ADVANCED TO THE 1ST DIAGONAL AND THE 15MM X 3.50MM NC QUANTUM APEX INTO THE PROXIMAL ¿ MID LAD WHERE A KISSING BALLOON TECHNIQUE (KBT) WAS PERFORMED. THE NC QUANTUM APEX MR BALLOON CATHETER BECAME "ENTWINED" WITH THE NON-BSC BALLOON AND NON-BSC GUIDE WIRE. RESISTANCE AND ¿EXCESSIVE FORCE¿ WAS USED DURING KBT. NEXT, THE PHYSICIAN PULLED THE NC QUANTUM APEX MR BALLOON CATHETER AND A SHAFT FRACTURE OCCURRED. THE FRACTURED SHAFT WAS SUCCESSFULLY RETRIEVED WITH A SNARE. POST IVUS WAS PERFORMED WITH A NON-BSC CATHETER AND REVEALED THAT THE STENT HAD GOOD APPOSITION. NO FURTHER 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 A SHAFT FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED DENOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A NC QUANTUM APEX MR 15MM X 3.50MM BALLOON CATHETER WAS INFLATED ONCE TO 6 ATMS TO PRE DILATE THE LESION. A PROMUS STENT WAS IMPLANTED. AN UNKNOWN SIZED NON-BSC BALLOON WAS ADVANCED TO THE 1ST DIAGONAL AND THE15MM X 3.50MM NC QUANTUM APEX INTO THE PROXIMAL ¿ MID LAD WHERE A KISSING BALLOON TECHNIQUE (KBT) WAS PERFORMED. THE NC QUANTUM APEX MR BALLOON CATHETER BECAME "ENTWINED" WITH THE NON-BSC BALLOON AND NON-BSC GUIDE WIRE. RESISTANCE AND "EXCESSIVE FORCE" WAS USED DURING KBT. NEXT, THE PHYSICIAN PULLED THE NC QUANTUM APEX MR BALLOON CATHETER AND A SHAFT FRACTURE OCCURRED. THE FRACTURED SHAFT WAS SUCCESSFULLY RETRIEVED WITH A SNARE. POST IVUS WAS PERFORMED WITH A NON-BSC CATHETER AND REVEALED THAT THE STENT HAD GOOD APPOSITION. NO FURTHER 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 H7493912415350 13891372

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BALLOON CATHETER, TAZUNA| GUIDE WIRE, RINATO| GUIDE CATHETER, 7FR LAUNCHER LJ4