BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2031920 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02067
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD AND CONTRAST VISIBLE ON THE SHAFT CONSISTENT WITH HANDLING. THERE WAS CONTRAST IN THE INFLATION LUMEN AND THE LOOSELY FOLDED BALLOON IS CONSISTENT WITH PREPARATION. THE PROXIMAL END OF THE BALLOON WAS BUNCHED, WHICH LIKELY OCCURRED AS RESISTANCE WAS ENCOUNTERED DURING RETRACTION. THERE WAS A NON-ABBOTT GUIDE WIRE INSIDE THE CATHETER WITH 13.7 CM OF THE GUIDE WIRE EXTENDING OUT THE TIP OF THE CATHETER. THE RETURNED GUIDE WIRE WAS EASILY REMOVED FROM THE CATHETER. WITH THE GUIDE WIRE BACK LOADED INTO THE CATHETER, A NEW INDEFLATOR WAS USED TO PRESSURIZE THE BALLOON, AND AT 10 ATMOSPHERES THE GUIDE WIRE BECAME STUCK IN THE CATHETER. THE INNER MEMBER INSIDE THE BALLOON, PROXIMAL TO THE MARKER HAD COLLAPSED. WHEN NEGATIVE WAS PULLED THERE WAS RESISTANCE MOVING THE GUIDE WIRE DUE TO THE COLLAPSED INNER MEMBER. THE DISTAL SHAFT PROXIMAL TO THE BALLOON AND THE TIP WERE CUT TO REMOVE THE INNER MEMBER. A NEW .014 GUIDE WIRE WAS ADVANCED THROUGH THE TIP AND THE PIECE OF INNER MEMBER WITHOUT RESISTANCE. INNER MEMBER COLLAPSE CAN OCCUR IF A GUIDE WIRE IS NOT INSERTED INTO THE GUIDE WIRE LUMEN DURING INFLATION OR DURING PREPARATION FOR USE OR FROM MULTIPLE/HIGH PRESSURE INFLATIONS; HOWEVER, AS THE GUIDE WIRE WAS NOTED TO BE INSERTED IN THE GUIDE WIRE LUMEN OF THE MINI TREK, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF 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 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. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, AS A CONCLUSIVE CAUSE FOR THE NOTED INNER MEMBER COLLAPSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT ANTERIOR DESCENDING ARTERY INTERVENTIONAL PROCEDURE, A NON-ABBOTT GUIDE WIRE WAS PLACED AND THE 1.5 X 12 MM TREK BALLOON WAS ADVANCED OVER THE GUIDE WIRE TO THE LESION. AFTER 3 INFLATIONS AT 10 ATMOSPHERES, THE BALLOON WAS ATTEMPTED TO BE REMOVED, BUT WAS STUCK ON THE GUIDE WIRE. THE BALLOON WAS NOTED TO ACCORDIAN UPON ATTEMPTED REMOVAL. THE GUIDE WIRE AND BALLOON CATHETER WERE REMOVED AS ONE UNIT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0091561

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR GUIDE WIRE: CORDIS ATW MARKER WIRE .014