BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1242900 · Received November 19, 2008

    Report

    Report Number
    2134265-2008-04375
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING (LAD) AND LEFT CIRCUMFLEX (LCX). THE PHYSICIAN WAS USING THE QUANTUM MAVERICK 4.5X12MM FOR POST DILATION OF AN UNSPECIFIED STENT; HOWEVER, THE BALLOON RUPTURED AT 14 ATM. THE NUMBER OF INFLATIONS AND TO WHAT ATMS IS UNK. THE DEVICE WAS REMOVED INTACT AND THERE WERE NO PT COMPLICATIONS REPORTED AND STATUS POST PROCEDURE WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 12X4.5 MM 11844113

    Patients

    Seq Age Sex Outcome Treatment
    1