BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2200896 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03510
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION BY MFR: THE AMPLATZ S/S XCH GUIDE WIRE WAS RECEIVED FOR ANALYSIS WITH A PART OF AN UNKNOWN CATHETER ATTACHED TO THE PROXIMAL END. VISUAL INSPECTION REVEALED THAT AN APPROXIMATELY 1CM SECTION OF THE TEFLON COATING WAS SCRAPED AT 70 CM FROM THE DISTAL END. DIMENSIONAL ANALYSIS REVEALED THE OUTER DIAMETER OF THE DEVICE TO BE WITHIN SPECIFICATIONS. NO PROBLEMS WERE NOTICED DURING REMOVAL OF THE WIRE FROM THE CATHETER. THE MANUFACTURING RECORD CONFIRMED THAT THE DEVICE MEET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATION CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 # 2134265-2011-04605.IT WAS FURTHER REPORTED THAT AN ADDITIONAL 035/260 AMPLATZ S/S XCH GUIDE WIRE BECAME STUCK IN A NON-BSC GUIDE CATHETER. THE GUIDE WIRE WAS REMOVED SUCCESSFULLY FROM THE GUIDE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE GUIDE WIRE BECAME STUCK IN THE CATHETER. THE 100% STENOSED, TOTALLY OCCLUDED LESION WAS LOCATED IN A MILDLY CALCIFIED AND MILDLY TORTUOUS TIBIAL VESSEL. AS THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE WIRE TO THE TARGET LESION THE (B)(4) AMPLATZ S/S XCH GUIDE WIRE BECAME STUCK IN A NON-BSC GUIDE CATHETER. THE WIRE WAS UNABLE TO BE ADVANCED OR WITHDRAWN AND THE CATHETER AND GUIDE WIRE WERE REMOVED TOGETHER AS ONE UNIT. VASCULAR ACCESS WAS LOST. THE PROCEDURE WAS COMPLETED WITH A NON-BSC GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001465260 14192482

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) QUICK CROSS CATHETER (SPECTRANETICS)