BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2142078 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02483
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THERE WAS BLOOD AND CONTRAST IN THE WIRE LUMEN AND BALLOON. THERE WAS A HOLE IN THE SHAFT WITH SCRATCHES ON THE OUTER SURFACE SURROUNDING THE HOLE 10CM FROM THE DISTAL TIP. THE BALLOON WAS TIGHTLY FOLDED AND THE STENT WAS CENTERED BETWEEN THE MARKERBANDS. THE BALLOON BURST WAS NOT CONFIRMED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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 A STENTING TREATMENT PROCEDURE, A BALLOON PERFORATION OCCURRED. THE PHYSICIAN ATTEMPTED TO PLACE THE 2.25X8MM ION STENT, BUT WAS UNSUCCESSFUL DUE TO 'THE HEART BEATING TOO MUCH'. A BUDDY WIRE (NON-BSC GUIDE WIRE) TECHNIQUE WAS USED TO PLACE THE STENT. THE PHYSICIAN "PULLED NEGATIVE" AND IDENTIFIED BLOOD RETURNING FROM THE STENT DELIVERY SYSTEM (SDS). THE PHYSICIAN FELT THE NON-BSC GUIDE WIRE PERFORATED THE SDS BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER ION STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON PERFORATION OCCURRED. THE PHYSICIAN ATTEMPTED TO PLACE THE 2.25X8MM ION STENT, BUT WAS UNSUCCESSFUL DUE TO 'THE HEART BEATING TOO MUCH'. A BUDDY WIRE (NON-BSC GUIDE WIRE) TECHNIQUE WAS USED TO PLACE THE STENT. THE PHYSICIAN "PULLED NEGATIVE" AND IDENTIFIED BLOOD RETURNING FROM THE STENT DELIVERY SYSTEM (SDS). THE PHYSICIAN FELT THE NON-BSC GUIDE WIRE PERFORATED THE SDS BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER ION STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902408220 14012468

    Patients

    Seq Age Sex Outcome Treatment
    1 WHISPER GUIDE WIRE