BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 1935612 · Received December 22, 2010

    Report

    Report Number
    2134265-2010-05775
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 1, 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 MFR: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER WITH NO ORIGINAL PACKAGING. AN UNIDENTIFIED GUIDE WIRE WAS RECEIVED WITH THE DEVICE. THERE WAS DRIED CONTRAST VISIBLE IN THE DISTAL SHAFT AND BALLOON. THERE WAS NOT ANY DAMAGE TO THE DEVICE OR THE GUIDE WIRE. THE INNER DIAMETER (ID) OF THE TIP AND WIRE EXIT NOTCH WERE MEASURED AND FOUND TO MEET SPECIFICATIONS. THE RETURNED GUIDE WIRE WAS ADVANCED ALL THE WAY THROUGH THE WIRE LUMEN WITH NO RESISTANCE ENCOUNTERED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS DETERMINED TO BE USE/USER ERROR BECAUSE THE DEVICE WAS REPORTEDLY INFLATED ABOVE RATED BURST PRESSURE (RBP) WHICH MAY HAVE CONTRIBUTED TO THE REPORTED RESISTANCE BETWEEN A CATHETER AND GUIDE WIRE. (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, BALLOON REMOVAL DIFFICULTY OCCURRED. THE 75% STENOSED LESION WAS LOCATED IN THE NON CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75MM × 15MM PROMUS STENT WAS IMPLANTED AND POST-DILATATION WAS PERFORMED WITH THE 8MM X 2.75MM NC QUANTUM APEX PTCA DILATATION CATHETER. THE APEX DILATATION CATHETER INFLATED TO 20ATMS, THREE TIMES AND 24ATMS, ONCE. INTENSE RESISTANCE BETWEEN THE BALLOON CATHETER AND ANOTHER MANUFACTURER'S GUIDE WIRE WAS ENCOUNTERED UPON WITHDRAWAL. THE PROCEDURE WAS COMPLETED WITH THIS 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, BALLOON REMOVAL DIFFICULTY OCCURRED. THE 75% STENOSED LESION WAS LOCATED IN THE NON CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75MM × 15MM PROMUS STENT WAS IMPLANTED AND POST-DILATATION WAS PERFORMED WITH THE 8MM X 2.75MM NC QUANTUM APEX PTCA DILATATION CATHETER. THE APEX DILATATION CATHETER INFLATED TO 20ATMS, THREE TIMES AND 24ATMS, ONCE. INTENSE RESISTANCE BETWEEN THE BALLOON CATHETER AND ANOTHER MANUFACTURER¿S GUIDE WIRE WAS ENCOUNTERED UPON WITHDRAWAL. THE PROCEDURE WAS COMPLETED WITH THIS 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 13763830

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SION| STENT: PROMUS 2.75×15