BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 2933570 · Received January 29, 2013

    Report

    Report Number
    2024168-2013-00458
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    October 12, 2012
    Report Date
    January 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K081549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: OTHER: ASPIRIN, CLOPIDOGREL EMBOLIC PROTECTION: RX ACCUNET IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT A STENTING PROCEDURE TO TREAT A LESION IN THE MILDLY CALCIFIED RIGHT INTERNAL CAROTID ARTERY. AN ACCUNET EMBOLIC PROTECTION DEVICE WAS DEPLOYED AT THE TARGET SITE. AN UNSPECIFIED DILATATION CATHETER WAS ADVANCED INTO THE PATIENT ANATOMY AND PRE-DILATATION WAS PERFORMED. THE BALLOON DILATATION CATHETER WAS THEN REMOVED FROM THE PATIENT ANATOMY, ALONG WITH THE ACCUNET. PER PHYSICIAN, IT APPEARED THAT THE BALLOON CAUGHT ON THE ACCUNET GUIDE WIRE, AND AS THE DILATATION CATHETER WAS REMOVED, THE ACCUNET WAS ALSO REMOVED. IT WAS REPORTED THAT THERE WERE NO ADVERSE PATIENT EFFECTS. A SECOND ACCUNET EMBOLIC PROTECTION DEVICE WAS THEN DEPLOYED AT THE TARGET SITE. AN 8.0 X 30 MM ACCULINK STENT DELIVERY SYSTEM WAS THEN ADVANCED AND THE STENT DEPLOYED AT THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39032 RX ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 2062562

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR