BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2213067 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03230
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    March 16, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS 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. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE 60-65% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0X12MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS DEPLOYED AT 12ATMS. A 12X3.5MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. THE BALLOON WAS INFLATED IN THE PROXIMAL LAD TO 12ATMS. A TYPE B PROXIMAL EDGE DISSECTION WAS OBSERVED. ANOTHER PROMUS ELEMENT STENT WAS DEPLOYED AS PREVIOUSLY PLANNED TO TREAT THE PROXIMAL LESION. NO ADDITIONAL 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 H7493912412350 0014064970

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other 3.0X16MM PROMUS ELEMENT STENT