BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 1955404 · Received January 10, 2011

    Report

    Report Number
    2024168-2011-00208
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE DISTAL SHAFT AND CONTRAST IN THE INFLATION LUMEN AND BALLOON, WHICH IS CONSISTENT WITH HANDLING AND PREPARATION. THE BALLOON WAS LOOSELY FOLDED WHICH HIS CONSISTENT WITH PRESSURE APPLIED TO THE CATHETER. THERE WAS A KINK IN THE DISTAL SHAFT 4.5 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINK MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON WHEN FLUID LEAKED OUT OF A HOLE IN THE BALLOON AT THE DISTAL END OF A FLAP 3.5 MM PROXIMAL TO THE DISTAL BALLOON SEAL, CONFIRMING THE REPORTED LEAK. THE FLAP WAS 1MM IN LENGTH. THERE WAS A SECOND FLAP 2.5 MM PROXIMAL TO THE DISTAL BALLOON SEAL .5 MM IN LENGTH. FACTORS THAT MAY CONTRIBUTE TO A TEAR/RUPTURE IN THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIAL DISCREPANCIES, INTERACTIONS WITH OTHER DEVICES, PATIENT ANATOMY, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION OR TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. ANALYSIS NOTED TWO FLAPS OF TORN BALLOON MATERIAL. DAMAGE OF THIS TYPE CAN BE THE RESULT OF MATERIAL PROCESSING OR INCORRECT PREPARATION FOR USE. SEVERAL ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION FROM THE ACCOUNT AS TO THE EXACT DETAILS OF THE PROCEDURE; HOWEVER NO FURTHER INFORMATION WAS AVAILABLE. IT IS POSSIBLE THE RX TREK WAS NOT SOAKED PRIOR TO USE. IT SHOULD BE NOTED THE RX TREK INSTRUCTIONS FOR USE (IFU) STATES TO SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. IT IS POSSIBLE THAT THE HYDROPHILIC COATING ON THE BALLOON WAS NOT ACTIVATED UPON EXPOSURE TO MOISTURE SUCH THAT AS THE BALLOON WAS INFLATED, THE BALLOON MATERIAL TORE AND PEELED. 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. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON HAD A HOLE IN THE TIP. IT WAS DISCOVERED WHEN THE PRESSURE WAS PULLED TO NEGATIVE. THE DEVICE WAS NO LONGER USED. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0081061

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BMW .014