BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2220933 · Received August 23, 2011

    Report

    Report Number
    2024168-2011-05919
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 NC TREK RX DILATATION CATHETER NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION. THE BALLOON WAS TIGHTLY FOLDED. THE SHAFT WAS STRETCHED (NECKED) DISTAL TO THE GUIDE WIRE EXIT NOTCH, FOR A LENGTH OF 2MM. FACTORS THAT COULD HAVE CONTRIBUTED TO DIFFICULTY INFLATING THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL/LESION MORPHOLOGY AND PATIENT DISEASE STATE, CONTRAST CONCENTRATION, BALLOON MATERIALS, MANUFACTURING, INFLATION LUMEN OBSTRUCTION, INTERACTION WITH ACCESSORIES (INDEFLATOR, ROTATING HEMOSTATIC VALVE, OR GUIDING CATHETER), PLACEMENT OF THE BALLOON WITHIN LESION, OR INFLATION TECHNIQUE. A NEW INDEFLATOR WAS FILLED WITH CONTRAST MEDIUM; DILUTED 1:1 WITH COLORED WATER AND WAS USED IN AN ATTEMPT TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP); HOWEVER, THE BALLOON WOULD NOT INFLATE TO RBP. THE BALLOON CATHETER WAS PLACED IN THE WATER BATH FOR 3 HOURS, AND A SECOND INFLATION ATTEMPT MADE, HOWEVER, THE BALLOON STILL WOULD NOT INFLATE. FLUID WAS UNABLE TO PASS THROUGH THE STRETCHED (NECKED) SHAFT. THERE WAS NO REPORTED DAMAGE OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTY EXPERIENCED DURING THE PROCEDURE. IT IS POSSIBLE THE SHAFT WAS INADVERTENTLY HANDLED DURING THE PREPARATION FOR USE, RESULTING IN THE STRETCHING NOTED TO THE SHAFT. IT WAS REPORTED THE BALLOON WAS NOT SOAKED PRIOR TO USE DURING PREPARATION. IT SHOULD BE NOTED THE NC TREK INSTRUCTIONS FOR USE (IFU) STATES TO SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. THE FAILURE TO SOAK THE BALLOON DOES NOT APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INFLATION DIFFICULTY. A REVIEW OF THE PRODUCT MANUFACTURING RECORD 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, THE REPORTED DIFFICULTY INFLATING THE BALLOON APPEARS TO BE RELATED TO THE STRETCHED SHAFT; HOWEVER A CONCLUSIVE CAUSE FOR THE STRETCHED AND DAMAGED SHAFT COULD NOT BE DETERMINED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE 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 DURING A PROCEDURE OF THE PROXIMAL RIGHT CORONARY ARTERY, THE 3.5 MM X 15 MM NC TREK BALLOON CATHETER WAS POSITIONED AT THE TARGET LESION BUT THE BALLOON WOULD NOT INFLATE; THE DEVICE WAS NOT PREPPED PER THE INSTRUCTIONS FOR USE. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT INCIDENT. THE BALLOON WAS ATTEMPTED TO BE INFLATED OUTSIDE THE ANATOMY BUT STILL COULD NOT BE INFLATED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. A SECOND 3.5 MM X 15 MM NC TREK WAS USED WITH THE SAME ABBOTT INDEFLATOR IN THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1022561

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR INFLATION: ABBOTT INDEFLATOR