BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3894825 · Received June 25, 2014

    Report

    Report Number
    2134265-2014-03972
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    January 18, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 MAUDE REPORT MW5036510. ADDITIONAL ANGIOGRAPHIC IMAGING IDENTIFIED REOCCLUSION OF THE BASILAR ARTERY. THE EMERGE MR 3.0X20MM BALLOON CATHETER AND A NEW .014 MICROWIRE WERE INSERTED WITH THE GUIDE CATHETER WERE ADVANCED INTO THE LEFT VERTEBRAL ARTERY UNDER FLUOROSCOPIC GUIDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WIRE CAUGHT ON A CATHETER. THE PATIENT PRESENTED WITH A SIGNIFICANT OCCLUSION OF THE SUPERIOR CEREBRAL ARTERY (SCA). THE GUIDE CATHETER WAS ADVANCED TO THE VERTEBRAL ARTERY UNDER FLUOROSCOPIC GUIDANCE. THE NON-BSC MICRO WIRE WAS POSITIONED IN THE RIGHT SCA. A 2.0X20MM EMERGE BALLOON CATHETER WAS ADVANCED OVER THE NON-BSC MICRO WIRE AND ANGIOPLASTY WAS PERFORMED TO NOMINAL ATM. POST ANGIOGRAPHY THERE WAS PRESENCE OF FLOW WITHIN BASILAR ARTERY AND DISTAL. THEN A 3.0X20MM EMERGE BALLOON CATHETER WAS ADVANCED TO THE MAXIMAL STENOSIS WITHIN THE BASILAR ARTERY AND INFLATED TO NOMINAL PRESSURE AND THE BALLOON WAS DEFLATED. THE ATTEMPT TO RETRACT THE MICRO WIRE FROM THE SCA MET WITH RESISTANCE. FLUOROSCOPIC IMAGING IDENTIFIED THE PRESENCE OF THE MICRO WIRE "SNAG" WITHIN THE RIGHT SCA. MULTIPLE MANEUVERS WERE PERFORMED IN AN ATTEMPT TO DISLODGE THE MICRO WIRE FROM THE RIGHT SCA. THE MICRO WIRE WAS UNDER TENSION WHICH RESULTED IN A FRACTURE OF THE MICRO WIRE. THE FRACTURED MICRO WIRE AND BALLOON DELIVERY SYSTEM WERE THEN RETRIEVED FROM THE SHEATH. "SO PART OF THAT WAS LEFT IN" PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370001 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493918920300

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR