BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM PLUS¿

    MDR report key: 5787953 · Received July 12, 2016

    Report

    Report Number
    2134265-2016-06201
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    June 21, 2016
    Report Date
    June 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K945379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE PLATINUM PLUS WAS RECEIVED INSIDE THE RENEGADE HI FLO DEVICE. THE PLATINUM PLUS WAS REMOVED FROM THE RENEGADE WITHOUT RESISTANCE. THE DEVICE HAS THE SPRING TIP SEVERELY DAMAGED AND STRETCHED. ALL THE OUTER DIMENSIONS WERE FOUND WITHIN SPECIFICATION. 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

    SAME CASE AS MDR ID: 2134265-2016-06202. IT WAS REPORTED THAT WIRE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED INSIDE THE VESSEL OF THE GASTROINTESTINAL TRACT. A 018/180 PLATINUM PLUS AND A 150/10 RENEGADE HI-FLO WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PLATINUM PLUS GUIDEWIRE WAS STUCK TOGETHER WITH THE RENEGADE HI-F-FLO MICROCATHETER INSIDE A NON-BSC DIAGNOSTIC CATHETER. THE WHOLE SYSTEM WAS REMOVED FROM THE PATIENTS' BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENTS' STATUS WAS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-06202. IT WAS REPORTED THAT WIRE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED INSIDE THE VESSEL OF THE GASTROINTESTINAL TRACT. A 018/180 PLATINUM PLUS¿ AND A 150/10 RENEGADE¿ HI-FLO¿ WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PLATINUM PLUS¿ GUIDEWIRE WAS STUCK TOGETHER WITH THE RENEGADE¿ HI-FLO¿ MICROCATHETER INSIDE A NON-BSC DIAGNOSTIC CATHETER. THE WHOLE SYSTEM WAS REMOVED FROM THE PATIENTS' BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENTS' STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439936 PLATINUM PLUS¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001466040 16571108

    Patients

    Seq Age Sex Outcome Treatment
    1