BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX BALLOON CATHETER

    MDR report key: 1801776 · Received August 16, 2010

    Report

    Report Number
    2134265-2010-03778
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: 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. ACCESS WAS GAINED VIA THE LEFT FEMORAL ARTERY USING A 6FR SHEATH. THERE WERE TWO TARGET LESIONS. FIRST, A DIFFUSE, HIGH RISK CLASS "C", 24MM LONG AND 70% STENOSED LESION LOCATED IN THE CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH TIMI-3 FLOW. FOLLOWING ANGIOGRAPHY, A 2.0X20MM MAVERICK2 BALLOON WAS ADVANCED AND INFLATED TWICE AT 12ATM. THEN A 3.0X28MM TAXUS LIBERTE WAS ADVANCED AND DEPLOYED IN THE TARGET LESION AT 20ATM FOR 26 SECONDS FOLLOWED BY POST DILATION WITH A 3.5X12MM QUANTUM MAVERICK BALLOON INFLATED 3 TIMES TO 16ATM. THE FINAL RESULT WAS 0% RESIDUAL STENOSIS AND TIMI-3 FLOW. SECOND, A COMPLEX, MEDIUM RISK CLASS "B", 12MM LONG AND 90% STENOSED LESION LOCATED IN THE MID 1ST DIAGONAL ARTERY WITH TIMI-3 FLOW. IT WAS TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY USING A 2.0X30MM APEX BALLOON CATHETER INFLATED AT 14ATM FOR 75 SECONDS. A DISSECTION WAS NOTED IN THE DIAGONAL WHICH WAS TREATED WITH ADDITIONAL BALLOON DILATION USING A 3.5X12MM QUANTUM MAVERICK BALLOON INFLATED TO 16ATMFOR 16 SECONDS. FOLLOWING TREATMENT RESIDUAL STENOSIS WAS 20% AND TIMI FLOW WAS 3. THE EVENT WAS REPORTED TO BE RESOLVED AND THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK21

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention CHOICE PT EXTRA SUPPORT 0.014 GUIDE WIRE X 2| MAVERICK BALLOON 2.0X20MM| QUANTUM MAVERICK BALLOON 3.5X12MM| 3.0X28MM TAXUS LIBERTE STENT| 6F RUNWAY GUIDE CATHETER