BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1673986 · Received May 5, 2010

    Report

    Report Number
    2134265-2010-02160
    Event Type
    Death
    Date Received
    May 5, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT 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

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A VESSEL PERFORATION AND PATIENT DEATH OCCURRED. THE LESION WAS 95% STENOSED CONCENTRIC LESION MEASURING APPROXIMATELY 2.5MM IN DIAMETER AND 12MM IN LENGTH WAS IN-STENT RESTENOSIS OF AN UNKNOWN STENT PLACED IN A MILDLY CALCIFIED AND NON-TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). TIMI FLOW THROUGH THE LAD WAS I. VASCULAR ACCESS WAS THE RIGHT FEMORAL ARTERY. A 3.0X30MM MAVERICK2 BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 15 ATMS FOR 30 SECONDS, ROTATED AND THEN INFLATED A SECOND TIME TO 10 ATMS FOR 30 SECONDS. ON THE SECOND INFLATION A PERFORATION OCCURRED. THE PATIENT EXPERIENCED SEVERE CHEST PAIN FOLLOWED BY HYPOTENSION AND CARDIAC ARREST. THE PATIENT WAS STARTED ON FENTANYL AND A DOPAMINE INFUSION. THE PHYSICIAN ATTEMPTED TO TREAT THE PERFORATION WITH A NON BSC STENT, BUT WAS UNSUCCESSFUL. CARDIOPULMONARY RESUSCITATION WAS STARTED AND THE PATIENT WAS INTUBATED. THE ADVANCED CARDIAC LIFE SUPPORT (ACLS) PROTOCOL WAS FOLLOWED; HOWEVER, THE PATIENT EXPIRED IN THE CATH LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892830300 0013273900

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death PT2 GUIDEWIRE| 6FR JL4 GUIDE CATHETER