BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA?

    MDR report key: 3843839 · Received June 2, 2014

    Report

    Report Number
    2134265-2014-02940
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    February 18, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIP
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT WAS DETACHED FROM THE SDS. THERE WERE STENT STRUTS THAT WERE BENT. THE SHAFT WAS BUCKLED AT THE DISTAL END OF THE NOSE CONE. THERE WAS A KINK 3.5CM FROM THE DISTAL END OF THE NOSE CONE. THE OD OF THE OUTER (BLUE) SHEATH AND MIDDLE (SILVER) SHEATH WERE WITHIN SPECIFICATION. THE INTRODUCER SHEATH USED IN THE CLINICAL EVENT WAS NOT RETURNED SO A 6F SUPER SHEATH WAS USED FOR FUNCTIONAL TESTING. THE INNER DIAMETER (ID) OF THE INTRODUCER SHEATH WAS MEASURED WITH A CALIBRATED PIN GAGE SET AND MEASURED .083¿. THE SDS WAS COMPLETELY ADVANCED THROUGH THE SUPER SHEATH WITH NO UNUSUAL RESISTANCE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. PRODUCT ANALYSIS COULD NOT CONFIRM THE REPORTED INSERTION DIFFICULTY. 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

    REPORTABLE UPON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT THERE WAS RESISTANCE WHILE DURING INSERTION. USING A 6FR NON-BSC INTRODUCER CATHETER, THE PHYSICIAN BEGAN TO ADVANCE A 5X40X75 INNOVA STENT DELIVERY SYSTEM (SDS). HOWEVER, RESISTANCE WAS EXPERIENCED AND THE SDS WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. DEVICE ANALYSIS FOUND STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321368 INNOVA? STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC - MAPLE GROVE H74939180054070 16525284

    Patients

    Seq Age Sex Outcome Treatment
    1