BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2081848 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03295
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HO
    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. GUIDE WIRE: COUGAR; INFLATION: EVEREST; GUIDE CATH: JCL5 MDT; SHEATH: 6 FR. EVALUATION SUMMARY: EVALUATION OF THE RETURNED MINI TREK NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN AND LOOSELY FOLDED BALLOON, CONSISTENT WITH PREPARATION, THE CATHETER ADVANCED INTO THE PATIENT ANATOMY AND THE BALLOON INFLATED. THE DISTAL BALLOON SHOULDER AND TAPER WERE PUSHED DISTALLY CAUSING THE BALLOON TO FOLD OVER ITSELF. THE OUTER MEMBER WAS NECKED AT THE DISTAL END OF THE LAP JOINT FOR A LENGTH OF 1 MM. THE DISTAL SHAFT WAS TORN AT THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 3 MM. THE TEARING OF THE GUIDE WIRE EXIT NOTCH APPEARS TO HAVE RESULTED FROM AN INTERACTION WITH THE GUIDE WIRE. THIS TYPE OF MECHANICAL DAMAGE CAN OCCUR IF AN ATTEMPT IS MADE TO PULL THE CATHETER IN AN OPPOSITE DIRECTION AS THE GUIDE WIRE. FACTORS WHICH CAN CONTRIBUTE TO DEFLATION ISSUES INCLUDE, BUT ARE NOT LIMITED TO, LESION CHARACTERISTICS, PATIENT ANATOMICAL MORPHOLOGY, PRE-DILATATION STRATEGY, DEFLATION TECHNIQUE, INADEQUATE CONNECTION TO THE INDEFLATOR, OR CONTAMINATION IN THE INFLATION LUMEN. A NEW INDEFLATOR FILLED WITH GASTROGRAFIN, DILUTED 1:1 WITH WATER WAS USED TO PRESSURIZE THE BALLOON CATHETER. THE FLUID DID NOT ADVANCE PAST THE NECKED OUTER MEMBER AND THE BALLOON DID NOT INFLATE. THERE WAS NO REPORT OF ANY DAMAGE NOTED TO THE CATHETER DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IT IS POSSIBLE THAT IF RESISTANCE WAS ENCOUNTERED DURING RETRACTION OF THE CATHETER, AS THE BALLOON WOULD NOT DEFLATE, AND AS FORCE WAS APPLIED, THE BALLOON WOULD FOLD OVER ITSELF AND THE SHAFT BECAME STRETCHED, FURTHER CONTRIBUTING TO THE BALLOON UNABLE TO DEFLATE; HOWEVER A CONCLUSIVE CAUSE FOR THE DIFFICULTY DEFLATING THE BALLOON COULD NOT BE DETERMINED. 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 HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. THE INCIDENT CIRCUMSTANCES WILL BE MONITORED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION AND DEFLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INFLATION OF THE BALLOON, CONTRAST MEDIA APPEARED TO ONLY FILL HALF OF THE BALLOON (HORIZONTALLY) AND THE OTHER HALF WAS NOT VISIBLE. IT WAS NOTED TO BE UNUSUAL THAT CONTRAST MEDIA WAS IN THE UPPER HALF OF THE BALLOON AND NOT THE BOTTOM HALF DUE TO IT'S VISCOSITY. THE BALLOON COULD NOT BE DEFLATED, EVEN AFTER APPLYING NEGATIVE PRESSURE AND DISCONNECTING THE INDEFLATOR. THE BALLOON WAS REMOVED INFLATED IN ORDER TO PLACE A STENT. NO PATIENT EFFECTS WERE REPORTED. 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 0052761

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR