BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX BALLOON CATHETER

    MDR report key: 2031927 · Received March 28, 2011

    Report

    Report Number
    2134265-2011-00824
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#2134265-2011-00825 & #2134265-2011-00826. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE DIAGONAL ARTERY. AN NC QUANTUM BALLOON WAS INFLATED IN THE TARGET LESION. "SEVERE DOG BONING" WAS NOTED AND THE BALLOON RUPTURED. THE DEVICE WAS EXCHANGED FOR ANOTHER NC QUANTUM BALLOON AND THE SAME EVENT OCCURRED. THE BALLOON WAS EXCHANGED FOR A 3RD NC QUANTUM BALLOON. THE 3RD DEVICE WAS INFLATED BEYOND RATED BURST PRESSURE AND RUPTURED. REMOVAL DIFFICULTIES WERE ENOUNTERED AND THE DISTAL PORTION OF THE DEVICE SEVERED OFF INSIDE THE ARTERY. AN ATTEMPT TO RETRIEVE THE DEVICE FRAGMENT WITH A SNARE WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY FOR EMERGENT BYPASS SURGERY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK651

    Patients

    Seq Age Sex Outcome Treatment
    1