BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 3042408 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02078
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    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: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AN MAGNIFIED INSPECTION REVEALED NO DAMAGE. POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, AND A STREAM OF WATER EMITTED FROM A PINHOLE IN THE BALLOON WALL 5MM FROM THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2013-02079. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE INDEX PROCEDURE TREATED THE 75% STENOSED TARGET LESION LOCATED IN THE MILDLY CALCIFIED AND SEVERELY TORTUOUS MID RIGHT CORONARY ARTERY WITH A 3.0X12MM LIBERTE STENT. IN (B)(6) 2013, THE PATIENT PRESENTED WITH A 90% IN-STENT RESTENOSIS OF THE LIBERTE STENT. TREATMENT UTILIZED PRE-DILATION WITH AN UNSPECIFIED EMERGE BALLOON CATHETER AND THEN ATTEMPTED TO ADVANCE AN UNSPECIFIED LIBERTE STENT, BUT THE STENT WAS UNABLE TO CROSS THE LESION. NEXT A NON-BSC STENT WAS ADVANCED BUT IT ALSO WAS NOT ABLE TO CROSS THE LESION AND DISTAL STENT DAMAGE OCCURRED. THEN THE UNSPECIFIED LIBERTE STENT WAS RE-ADVANCED VIA A 4 FR EXTENSION CATHETER AND WAS SUCCESSFULLY DEPLOYED. FINALLY THE LESION WAS POST DILATED WITH A 3.5X15MM NC QUANTUM APEX BALLOON, HOWEVER, THE BALLOON RUPTURED AT 16 ATMS ON THE 2ND INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2013-02079. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE INDEX PROCEDURE TREATED THE 75% STENOSED TARGET LESION LOCATED IN THE MILDLY CALCIFIED AND SEVERELY TORTUOUS MID RIGHT CORONARY ARTERY WITH A 3.0X12MM LIBERTE STENT. IN (B)(6) 2013, THE PATIENT PRESENTED WITH A 90% IN-STENT RESTENOSIS OF THE LIBERTE STENT. TREATMENT UTILIZED PRE-DILATION WITH AN UNSPECIFIED EMERGE BALLOON CATHETER AND THEN ATTEMPTED TO ADVANCE AN UNSPECIFIED LIBERTE STENT, BUT THE STENT WAS UNABLE TO CROSS THE LESION. NEXT A NON-BSC STENT WAS ADVANCED BUT IT ALSO WAS NOT ABLE TO CROSS THE LESION AND DISTAL STENT DAMAGE OCCURRED. THEN THE UNSPECIFIED LIBERTE STENT WAS RE-ADVANCED VIA A 4 FR EXTENSION CATHETER AND WAS SUCCESSFULLY DEPLOYED. FINALLY THE LESION WAS POST DILATED WITH A 3.5X15MM NC QUANTUM APEX BALLOON, HOWEVER THE BALLOON RUPTURED AT 16 ATMS ON THE 2ND INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146605 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415350 14405766

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED INTEGRITY STENT| 3.0X12MM LIBERTE STENT| UNSPECIFIED LIBERTE STENT