BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2091955 · Received May 18, 2011

    Report

    Report Number
    2024168-2011-03528
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. ABOVE RATED BURST PRESSURE. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND THE CATHETER BEING ADVANCED OVER A GUIDE WIRE. THE BALLOON WAS LOOSELY FOLDED. THE NON ABBOTT GUIDE WIRE THAT WAS USED DURING THE PROCEDURE WAS ALSO RETURNED. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE. AN ATTEMPT WAS MADE TO ADVANCE A MANDREL THROUGH THE GUIDE WIRE LUMEN; HOWEVER, THE MANDREL DID NOT ADVANCE THROUGH THE DISTAL END OF THE GUIDE WIRE LUMEN. THE MANDREL STOPPED 7.5 CM PROXIMAL TO THE BALLOON MARKER. AT NEUTRAL PRESSURE, AN ATTEMPT WAS MADE TO BACKLOAD THE RETURNED GUIDE WIRE THROUGH THE GUIDE WIRE LUMEN, BUT THE GUIDE WIRE DID NOT ADVANCE PAST THE PROXIMAL BALLOON SEAL. AFTER THE BALLOON CATHETER WAS PRESSURIZED TO THE RATED BURST PRESSURE (RBP) OF 14 ATMOSPHERES (ATM), IT WAS NOTED THAT THE INNER MEMBER WAS COLLAPSED FOR A LENGTH OF 8 CM FROM THE TIP. INNER MEMBER COLLAPSE CAN BE A RESULT OF A MATERIAL DISCREPANCY, INCORRECT PREPARATION FOR USE, GUIDE WIRE SIZE SELECTION, OR HIGH PRESSURE/MULTIPLE INFLATIONS. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE INNER MEMBER COLLAPSE COULD NOT BE DETERMINED. ADDITIONALLY, IT WAS REPORTED THE MINI TREK WAS INFLATED TO 16ATM, WHICH IS ABOVE THE RBP OF 14ATM. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE STATES: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULTY REMOVING THE GUIDE WIRE OR INNER MEMBER COLLAPSE FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT IS 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED LESION IN THE RIGHT CORONARY ARTERY. THE MINI TREK BALLOON WAS ADVANCED WITHOUT DIFFICULTY OVER A NON-ABBOTT GUIDE WIRE TO THE TARGET LESION AND INFLATED 10 TIMES AT A MAXIMUM OF 16 ATMOSPHERES FOR 10-15 SECONDS EACH INFLATION; HOWEVER, DURING REMOVAL, RESISTANCE WAS NOTED BETWEEN THE MINI TREK BALLOON AND THE GUIDE WIRE. IT WAS NOTED THAT THE MINI TREK WAS ABLE TO BE REMOVED, AND THE GUIDE WIRE WAS ABLE TO MAINTAIN VESSEL ACCESS. THE PROCEDURE WAS COMPLETED WITHOUT REPORT OF ANY ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS 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 010136Q

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR GUIDE WIRE: BROSS