BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION¿

    MDR report key: 3002760 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01477
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE BALLOON WAS TIGHTLY FOLDED AND THERE WAS NO INDICATION THE BALLOON WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE. THE TIP WAS DAMAGED. THE INNER SHAFT WAS BUCKLED ON BOTH SIDES OF THE DISTAL MARKERBAND AND FROM THE BI-COMPONENT BOND TO THE PROXIMAL END OF THE PROXIMAL MARKERBAND. THE ENTIRE LENGTH OF THE STENT WAS STRETCHED. THE STENT STRUTS WERE BENT AND DAMAGED. THERE WAS A COMPLETE INNER AND OUTER SHAFT SEPARATION DISTALLY FROM THE GUIDEWIRE EXIT NOTCH. THE FRACTURE FACES WERE JAGGED AND STRETCHED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD. MAGNIFIED INSPECTION OF THE FRACTURE SURFACE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE SEPARATION. THERE WAS NO EVIDENCE OF 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).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A CATHETER WAS ENTRAPPED ON A GUIDE WIRE AND A SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN WAS ATTEMPTING TO LOAD THE 2.75 X 38MM ION MR STENT DELIVERY SYSTEM (SDS) OVER THE 300 NON BSC GUIDE WIRE AND IT "LOCKED UP" BEFORE ENTERING THE PATIENT. THE SDS SHAFT BROKE IN HALF. THE SDS WAS REMOVED FROM THE GUIDE WIRE AND ANOTHER 2.75 X 38MM ION STENT WAS DEPLOYED OVER THE SAME GUIDE WIRE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A CATHETER WAS ENTRAPPED ON A GUIDE WIRE AND A SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN WAS ATTEMPTING TO LOAD THE 2.75 X 38MM ION MR STENT DELIVERY SYSTEM (SDS) OVER THE 300 NON BSC GUIDE WIRE AND IT "LOCKED UP" BEFORE ENTERING THE PATIENT. THE SDS SHAFT BROKE IN HALF. THE SDS WAS REMOVED FROM THE GUIDE WIRE AND ANOTHER 2.75 X 38MM ION STENT WAS DEPLOYED OVER THE SAME GUIDE WIRE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104924 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902438270 14861456

    Patients

    Seq Age Sex Outcome Treatment
    1 300 BMW: GUIDE WIRE