BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRO ELITE SNARE

    MDR report key: 2001866 · Received February 25, 2011

    Report

    Report Number
    1225894-2011-00001
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 1, 2009
    Report Date
    January 31, 2011
    Manufacturer
    AV-RADIUS
    Product Code
    MMX
    PMA / PMN Number
    071457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS WAS PERFORMED BY THE MANUFACTURER RADIUS MEDICAL TECHNOLOGIES. ANALYSIS REVEALED THAT ONE LEG OF THE LOOP WAS FRACTURED NEAR THE DISTAL COLLAR. ALL MATERIALS/COMPONENTS ARE PRESENT. IT IS HIGHLY UNLIKELY THAT THIS PRODUCT WAS EVER USED IN A PATIENT AS THERE IS NO EVIDENCE OF BLOOD OR OTHER FLUID ON OR IN THE SNARE. THIS WAS MOST LIKELY A DEMO PRODUCT THAT WAS DAMAGED AS PART OF ROUTINE DEMONSTRATIONS. A LOT HISTORY RECORD REVIEW WAS NOT INCLUDED IN THE INVESTIGATION BY MANUFACTURER. A REVIEW OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED WITH THIS PART AND LOT COMBINATION.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATION AS IT WAS REPORTED TO HAVE OCCURRED APPROXIMATELY 2 YEARS AGO. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. ABBOTT VASCULAR DISTRIBUTES THE EXPRO ELITE SNARE FOR RADIUS MEDICAL. ABBOTT VASCULAR PROVIDES US REGULATORY REPORTING FOR THIS PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT SHREDDED. THE DEVICE WAS RECEIVED WITH A SEPARATION. IT CANNOT BE CONFIRMED IF THIS PRODUCT WAS USED ON A PATIENT OR WAS A DEMO PRODUCT; HOWEVER, THERE WERE NO REPORTED PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRO ELITE SNARE SNARE MMX AV-RADIUS 07W14204

    Patients

    Seq Age Sex Outcome Treatment
    1