BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3122561 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03505
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE EMERGE CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS A COMPLETE SEPARATION OF THE HYPOTUBE. THE HYPOTUBE SEPARATION WAS 64.5CM FROM THE EDGE OF THE STRAIN RELIEF. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. PRODUCT ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED INFORMATION. THERE WAS NO EVIDENCE THAT THE SEPARATION WAS ATTRIBUTABLE TO ANY PRODUCT QUALITY DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRODUCTION FOR A PERCUTANEOUS CORONARY INTERVENTION, SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS PROXIMAL AND DISTAL OF LEFT CIRCUMFLEX (LCX). A 12MM X 2.50MM EMERGE BALLOON CATHETER WAS ADVANCED AND PREDILATED THE DISTAL PART OF THE LCX. AFTER PREDILATION, AN UNSPECIFIED STENT WAS DEPLOYED. SUBSEQUENTLY,THE PHYSICIAN ATTEMPTED TO USE THE THIS DEVICE TO PERFORM DILATION AT PROXIMAL END OF LCX. THE PHYSICIAN FOUND THAT THE SHAFT OF THE DEVICE WAS SEPARATED AND THE PROXIMAL SIDE OF SEPARATED AREA WAS FOUND TO BE KINKED. RESISTANCE WAS NOT FELT DURING INSERTION AND WITHDRAWAL OF THE BALLOON CATHETER DURING PREDILATION OF THE LESION AT THE DISTAL LCX. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224975 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919312250 15687071

    Patients

    Seq Age Sex Outcome Treatment
    1