BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPT?

    MDR report key: 3200948 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04516
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    April 21, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIM
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE ADAPT CATHETER WAS RECEIVED WITH A .014" NON-BSC GUIDEWIRE LODGED INSIDE THE LUMEN OF THE CATHETER. THERE WAS SOLIDIFIED BLOOD IN THE WIRE LUMEN. THERE WAS A COMPLETE SHAFT SEPARATION 25 CM FROM THE TIP. THE GUIDEWIRE WAS PROTRUDING 2.5 CM FROM THE TIP. GENTLY PULLING ON THE WIRE CONFIRMED THAT THE WIRE WAS STUCK IN THE LUMEN OF THE CATHETER. THE STENT WAS CORRECTLY POSITIONED. THERE WAS NO OTHER DAMAGE OR IRREGULARITIES. FUNCTIONAL TESTING TO DEPLOY THE STENT COULD NOT BE PERFORMED DUE TO THE SEPARATED SHAFT. 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013 IT WAS REPORTED THAT DURING A CAROTID STENTING TREATMENT PROCEDURE, THE STENT FAILED TO DEPLOY. THE TARGET LESION WAS LOCATED IN THE STENOSED INTERNAL CAROTID ARTERY (ICA). A 40 MM ADAPT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND PLACED IN THE TARGET LESION. THE STENT WOULD NOT DEPLOY DUE TO THE OUTER SHEATH FAILING TO RETRACT. THE SDS WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 40 MM ADAPT STENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE DELIVERY CATHETER WAS STUCK ON A GUIDE WIRE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303268 ADAPT? STENT, CAROTID NIM BOSTON SCIENTIFIC - MAPLE GROVE M001552040 15672401

    Patients

    Seq Age Sex Outcome Treatment
    1