BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2972885 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00994
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 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

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: MAGNIFIED INSPECTION OF THE RETURNED DEVICE REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL ON THE DISTAL END OF THE BALLOON. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL AND THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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).

    Description of Event or Problem · 1

    SAME CASE MDR ID# 2134265-2013-00993. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. AT UNSPECIFIED TIME DURING THE PROCEDURE A 15MM X 3.00MM NC QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. DURING AN UNKNOWN INFLATION AT APPROXIMATELY 19ATMS-20ATMS A BALLOON RUPTURE OCCURRED. THE NC QUANTUM APEX MR BALLOON CATHETER WAS REMOVED. ANOTHER 15MM X 3.00MM NC QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. DURING AN UNKNOWN INFLATION AT APPROXIMATELY 19ATMS-20ATMS A BALLOON RUPTURE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A NON BSC BALLOON CATHETER INFLATED TO 20ATMS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS DENOVO LOCATED IN THE SEVERELY CALCIFIED VESSEL. THE 15MM X 3.00MM NC QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED FOR POST DILATION AND THE BALLOON RUPTURED ON THE FIRST INFLATION. THE 15MM X 3.00MM NC QUANTUM APEX¿ MR BALLOON CATHETER WAS REMOVED INTACT. THE SECOND 15MM X 3.00MM NC QUANTUM APEX¿ MR BALLOON CATHETER WAS ADVANCED FOR POST DILATION AND THE BALLOON RUPTURED ON THE FIRST INFLATION. THE SECOND 15MM X 3.00MM NC QUANTUM APEX MR BALLOON CATHETER WAS REMOVED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77456 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415300 15382703

    Patients

    Seq Age Sex Outcome Treatment
    1