BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 1884857 · Received October 28, 2010

    Report

    Report Number
    2134265-2010-04802
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    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: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED BLOOD AND CONTRAST THROUGHOUT THE DISTAL LUMEN SHAFT AND A BEND IN THE HYPOTUBE APPROXIMATELY 53-1/2CM FROM DISTAL TIP. A SHAFT KINK WAS ALSO NOTED 22CM FROM DISTAL TIP. MICROSCOPIC EXAMINATION OF THE BALLOON REVEALED THAT THE INNER LUMEN INSIDE THE BALLOON APPEARED KINKED OR STRETCHED. NO BALLOON DAMAGE WAS FOUND. EXAMINATION OF THE MATERIAL SURROUNDING THE KINK DID NOT REVEAL ANY EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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 INTERVENTIONAL (PCI) PROCEDURE, A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 90% STENOSED AND DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PRE-DILATED WITH THE 2.50MM X 15MM NC QUANTUM APEX PTCA DILATATION CATHETER FOR TWO INFLATIONS, FIRST TO 12ATMS AND SECOND TO 20ATMS. ANOTHER MANUFACTURER¿S 2.5 X 23MM DRUG ELUTING STENT (DES) WAS IMPLANTED. UPON ATTEMPTING TO POST-DILATE THE STENT WITH THE NC QUANTUM APEX PTCA DILATATION CATHETER AT 30 ATMS, THE CATHETER KINKED AND SHAFT BROKE. SOME RESISTANCE WAS ENCOUNTERED UPON WITHDRAWAL. THE BALLOON CATHETER WAS REMOVED WITHOUT INCIDENT. 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 INTERVENTIONAL (PCI) PROCEDURE, A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 90% STENOSED AND DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PRE-DILATED WITH THE 2.50MM X 15MM NC QUANTUM APEX PTCA DILATATION CATHETER FOR TWO INFLATIONS, FIRST TO 12ATMS AND SECOND TO 20ATMS. ANOTHER MANUFACTURER'S 2.5 X 23MM DRUG ELUTING STENT (DES) WAS IMPLANTED. UPON ATTEMPTING TO POST-DILATE THE STENT WITH THE NC QUANTUM APEX PTCA DILATATION CATHETER AT 30 ATMS, THE CATHETER KINKED AND SHAFT BROKE. SOME RESISTANCE WAS ENCOUNTERED UPON WITHDRAWAL. THE BALLOON CATHETER WAS REMOVED WITHOUT INCIDENT. 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 H7493912415250 13685481

    Patients

    Seq Age Sex Outcome Treatment
    1 2.5X23 XIENCE STENT