BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM PLUS?

    MDR report key: 3833802 · Received May 27, 2014

    Report

    Report Number
    2134265-2014-02922
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K945379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: DEVICE PRESENTS TWO KINKS, ONE IS AT 248.5CM FROM PROXIMAL END, AND THE SECOND ONE IS AT 282 CM FROM THE PROXIMAL END. ADDITIONALLY, THE DISTAL TIP DAMAGED, WITH THE SPRING TIP ELONGATED AND THE ABSENCE OF THE BALL WELD. THE ENTIRE LENGTH OF THE WIRE WAS EXAMINED AND THE DEVICE RETURNED PRESENTS: THE DISTAL TIP SEVERELY DAMAGED (COILWIRE UNRAVELED AND COREWIRE FRACTURED). ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. THE RETURNED DEVICE WAS SENT FOR EXTERNAL ANALYSIS ((B)(4) LAB) TO DETERMINE THE FRACTURE FAILURE MODE. THE (B)(4) LAB RETURNED THE FOLLOWING RESULTS: FATIGUE OCCURRED DUE TO A CYCLIC BENDING FATIGUE. 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: 2134265-2014-02921. IT WAS REPORTED THAT A GUIDE WIRE PARTIAL BREAK OCCURRED. THE 2.5-3 INCH LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS, CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY. A TRUEPATH CHRONIC TOTAL OCCLUSION DEVICE WAS OPERATIONAL FOR APPROXIMATELY 20 MINUTES WITH GOOD AUDIO AND VISUAL FEEDBACK. APPROXIMATELY AN INCH OF PROGRESS WAS MADE IN THE LESION. AFTER 20 MINUTES, THE LED LIGHT ON THE CONTROL UNIT WOULD NOT ILLUMINATE. THE DEVICE WAS REMOVED FROM THE PATIENT AND TESTED ON THE BACK TABLE AND THE TIP WAS ABLE TO SPIN WITH RESISTANCE; HOWEVER, THE LIGHTS WOULD NOT ILLUMINATE. A SMALL PERFORATION WAS NOTED AFTER THE TRUEPATH WAS REMOVED THAT RESOLVED. THE DECISION WAS THEN MADE TO GO SUBINTIMAL WITH A STANDARD GUIDE WIRE. THE PHYSICIAN USED A NON-BSC GUIDE CATHETER WITH A PLATINUM PLUS GUIDE WIRE. IT WAS THEN NOTED THAT THE GUIDE WIRE HAD A PARTIAL BREAK AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHIN THE CATHETER. THE CASE WAS ABORTED WITH THE PATIENT UNTREATED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OK.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-02921. IT WAS REPORTED THAT A GUIDE WIRE PARTIAL BREAK OCCURRED. THE 2.5-3 INCH LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS, CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY. A TRUEPATH CHRONIC TOTAL OCCLUSION DEVICE WAS OPERATIONAL FOR APPROXIMATELY 20 MINUTES WITH GOOD AUDIO AND VISUAL FEEDBACK. APPROXIMATELY AN INCH OF PROGRESS WAS MADE IN THE LESION. AFTER 20 MINUTES, THE LED LIGHT ON THE CONTROL UNIT WOULD NOT ILLUMINATE. THE DEVICE WAS REMOVED FROM THE PATIENT AND TESTED ON THE BACK TABLE AND THE TIP WAS ABLE TO SPIN WITH RESISTANCE; HOWEVER THE LIGHTS WOULD NOT ILLUMINATE. A SMALL PERFORATION WAS NOTED AFTER THE TRUEPATH WAS REMOVED THAT RESOLVED. THE DECISION WAS THEN MADE TO GO SUBINTIMAL WITH A STANDARD GUIDE WIRE. THE PHYSICIAN USED A NON-BSC GUIDE CATHETER WITH A PLATINUM PLUS GUIDE WIRE. IT WAS THEN NOTED THAT THE GUIDE WIRE HAD A PARTIAL BREAK AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHIN THE CATHETER. THE CASE WAS ABORTED WITH THE PATIENT UNTREATED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311004 PLATINUM PLUS? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001467120 15730193

    Patients

    Seq Age Sex Outcome Treatment
    1 OUTBACK GUIDE CATHETER