BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVERICK BALLOON DILATION CATHETER

    MDR report key: 1841731 · Received September 22, 2010

    Report

    Report Number
    2134265-2010-04469
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    June 29, 2010
    Report Date
    August 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM, DEVICE LOT NUMBER, BATCH EXPIRATION DATE, BATCH MANUFACTURED DATE. (B)(4).

    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

    SAME CASE AS MFR REPORT #: 2134265-2010-04348, 2134265-2010-04468. (B)(4). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST DISCOMFORT, ISCHEMIC ST-SEGMENT CHANGES, AND PLAQUE SHIFT. THE PATIENT PRESENTED FOR THE PROCEDURE DUE TO CHEST PAIN AND AN ABNORMAL STRESS TEST. ACCESS WAS OBTAINED AT THE RIGHT RADIAL ARTERY WITH A 6F SHEATH. A 6F JACKY-CURVE CATHETER WAS USED FOR SELECTIVE ANGIOGRAPHY OF THE RIGHT AND LEFT CORONARY ARTERIES. LEFT HEART CATHETERIZATION AND LEFT VENTRICULOGRAPHY WAS PERFORMED WITH A 6F ANGLED PIG TAIL CATHETER. A 6F IKARI LEFT 3.5 GUIDE CATHETER INTRODUCED FOR INTERVENTION AND ENGAGED IN THE LEFT MAIN CORONARY ARTERY. A 0.014 LUGE GUIDE WIRE WAS INTRODUCED INTO THE FIRST OM (OBTUSE MARGINAL) BRANCH. THEN ATTEMPTS WERE MADE TO WIRE THE PRIMARY LESION IN THE DISTAL LCX (LEFT CIRCUMFLEX). SEVERAL COMBINATIONS OF BALLOONS AND WIRES WERE ATTEMPTED WITHOUT SUCCESS, INCLUDING A 1.5X9MM MAVERICK BALLOON, PT GRAPHIX GUIDE WIRE, AND TWO NON-BSC GUIDE WIRES UNTIL EVENTUALLY ONE OF THE NON-BSC GUIDE WIRES WAS SUCCESSFULLY PLACED. DURING THE DIFFICULTIES WITH THE BALLOON AND GUIDEWIRES, THE PATIENT COMPLAINED OF CHEST DISCOMFORT AND ISCHEMIC ST-SEGMENT CHANGES WERE OBSERVED. INTRAVENOUS NITROGLYCERIN AND A REOPRO BOLUS WERE INITIATED. THEN THE PRIMARY LCX LESION WAS DILATED WITH THE 1.5X9MM MAVERICK BALLOON TO 16ATM. NEXT A 2.5X12MM MAVERICK BALLOON WAS INFLATED WITH ANGIOGRAPHY SHOWING 70% RESIDUAL STENOSIS AND PLAQUE SHIFT WITHIN THE LARGE OM1 BRANCH. THE 2.5X12MM MAVERICK BALLOON WAS THEN USED TO DILATE THE OM1 BRANCH RESULTING IN RESIDUAL STENOSIS AND PLAQUE WITHIN THE LCX-OM BIFURCATION AND A BIFURCATION STENTING STRATEGY WAS PURSUED. A 3.0X12MM TAXUS STENT WAS PLACED IN THE OM1 WITH ATTEMPTS TO POSITION THE STENT AT THE OSTIUM. A 2.0X12MM MAVERICK BALLOON WAS POSITIONED IN THE MID LCX AS A BLOCKING BALLOON AND INFLATIONS WERE PERFORMED WITH THE MAVERICK BALLOON AND THE TAXUS STENT DELIVERY BALLOON. THE LCX WAS THEN TREATED WITH A 3.5X16MM TAXUS STENT DEPLOYED AT 10ATM. THE LUGE GUIDEWIRE WAS THEN REMOVED AND USED TO CROSS THE LCX STENT STRUTS INTO THE OM BRANCH. A 3.5X8MM APEX BALLOON WAS THEN USED TO DILATE THE MID LCX STENT AT 16-18ATM. FINAL KISSING BALLOON ANGIOPLASTY WAS PERFORMED TO THE LCX-OM BIFURCATION USING TWO 2.5X12MM MAVERICK BALLOONS WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW THROUGHOUT TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS NOT EMERGENT. THE PATIENT EXPERIENCED CHEST PAIN WHEN THE NON-BSC GUIDE WIRE CROSSED THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK BALLOON DILATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7492062009150 13146983

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 6F JACKY CATHETER| PT GRAPHIX GUIDE WIRE| 6F IKARI LEFT 3.5 GUIDE CATHETER| 6F RADIAL SHEATH| 0.014 LUGE GUIDE WIRE| 6F ANGLED PIGTAIL CATHETER| MIRACLE BROS 3 GUIDE WIRE| WHISPER GUIDE WIRE