BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 3173246 · Received June 17, 2013

    Report

    Report Number
    2024168-2013-03771
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: BALANCE MIDDLEWEIGHT; GUIDE CATH: 3.5 JR 6 FR. THE DEVICE WAS RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT DETACHMENT WAS CONFIRMED. THE REPORTED FAILURE TO CROSS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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 INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RIGHT RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE MILDLY TORTUOUS, HEAVILY CALCIFIED, 90% DE NOVO, PROXIMAL RIGHT CORONARY ARTERY THE 3.5 MM 6 FR JR GUIDE CATHETER WAS ENGAGED AND ANGIOGRAPHY PERFORMED. THE BALANCE MIDDLEWEIGHT (BMW) WAS ADVANCED ACROSS THE LESION AND PRE-DILATATION WITH A 1.2 X 6 MM MINI TREK BALLOON DILATATION CATHETER (BDC), 2 X 12 MM VOYAGER NC AT 10, 12, AND 16 ATMOSPHERE (ATM) RESPECTIVELY WAS COMPLETED. LATER A 2.25 X 12 MINI VISION STENT DELIVERY SYSTEM (SDS) WAS USED TO TRACK THE LESION BUT IT COULD NOT BE NEGOTIATED; DURING THE MANIPULATION THE SHAFT BROKE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. A DIFFERENT 2.25 X 12 MM MINI VISION SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273599 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2042341

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCOMITANT MEDICAL DEVICES