BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX BALLOON CATHETER

    MDR report key: 2880085 · Received December 19, 2012

    Report

    Report Number
    2134265-2012-08440
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    October 5, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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) STUDY. SAME PATIENT AS MDR ID#2134265-2012-06759. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE CHEST PAIN OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN AND THE PATIENT WAS HOSPITALIZED. ANGIOGRAPHY WAS PERFORMED THE DAY AFTER THE PATIENT WAS HOSPITALIZED. FOCAL RESTENOSIS WAS NOTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH MILD IN-STENT RESTENOSIS NOTED AS WELL. AN UNKNOWN IVUS CATHETER REVEALED THAT THE PREVIOUSLY IMPLANTED 2.50 MM X 16 MM ION STUDY STENT WAS UNDER-DEPLOYED. A 3.0 X 18 MM NON-BSC DRUG ELUTING NON-STUDY STENT WAS DEPLOYED TO TREAT THE RESTENOSIS. A NC QUANTUM APEX 3.0 X 20 MM BALLOON WAS USED FOR POST-DILATATION. FOLLOWING POST-DILATATION, THE SUBJECT EXPERIENCED EPISODES OF CHEST DISCOMFORT. ST SEGMENTS ELEVATIONS IN THE ANTERIOR AND LATERAL LEADS WERE ALSO NOTED. THE FOLLOWING DAY, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    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 68 YR Other