BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 2201178 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05675
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, CONSISTENT WITH THE SDS AT LEAST PARTIALLY ADVANCED OVER A GUIDE WIRE. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THERE WERE MULTIPLE BENDS IN THE ENTIRE LENGTH OF THE HYPOTUBE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES WITH THE GUIDE WIRE. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE SDS OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT ARE NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF THE SDS GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. TO ENSURE THIS IS NOT THE RESULT OF A PRODUCT DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE PROPER GUIDE WIRE REVERSIBILITY. AN ATTEMPT WAS MADE TO BACKLOAD A MANDREL AND A NEW .014 INCH GUIDE WIRE THROUGH THE SDS, BUT THERE WAS A BLOCKAGE 1 CM PROXIMAL TO THE DISTAL MARKER AND WAS NOT ABLE TO ADVANCE FURTHER. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. AFTER THE SDS WAS SOAKED IN THE WATER BATH TO DISSOLVE THE BLOOD IN THE GUIDE WIRE LUMEN, A NEW .014 INCH GUIDE WIRE WAS BACK LOADED THROUGH THE SDS AND REMOVED WITH NO RESISTANCE NOTED. THE BUILD UP OF BLOOD IN THE GUIDE WIRE LUMEN CONTRIBUTED TO THE REPORTED DIFFICULTIES. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NON-CONFORMING MATERIAL RECORDS FOR THE LOT RELATED TO THIS INCIDENT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO POSITION OR REMOVE THE GUIDE WIRE. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN DELIVERING THE MULTI-LINK 8 STENT DELIVERY SYSTEM (SDS) OVER THE GUIDE WIRE, STRONG FRICTION WAS FELT BETWEEN THE BMW UNIVERSAL II GUIDE WIRE AND THE SDS. ADDITIONALLY, RESISTANCE WAS ALSO FELT WHEN THE SDS WAS REMOVED FROM THE GUIDE WIRE. ANOTHER MULTI-LINK 8 3.0 X 28 MM WAS USED SUCCESSFULLY OVER THE SAME BMW UNIVERSAL II GUIDE WIRE WITHOUT ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0020961

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BMW UNIVERSAL II