BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2233579 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06148
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 10, 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. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. RETURN OF THE RX MINI TREK CATHETER USED IN THE PROCEDURE MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH ACCESSORY DEVICES, OR THE HEAVILY CALCIFIED LESION SUCH THAT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT 6 ATMOSPHERE. ADDITIONALLY, IT WAS REPORTED THE BALLOON WAS NOT SOAKED PRIOR TO USE WHICH ALSO MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE. IT SHOULD BE NOTED THE MINI 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; HOWEVER THIS COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC DEFICIENCY. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY. THE OTHER MINI TREK IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE 100% STENOSED, HEAVILY CALCIFIED, CONCENTRIC, DE NOVO, RIGHT CORONARY ARTERY LESION, THE 1.2 MM X 6 MM MINI TREK WAS ATTEMPTED FOR PRE-DILATATION, HOWEVER, DURING THE FIRST INFLATION AT 3 ATMOSPHERE (ATM) THE BALLOON RUPTURED. A 1.25 MM X 6 MM NON-ABBOTT BALLOON WAS USED WITHOUT INCIDENT. AN ADDITIONAL DILATATION WAS ATTEMPTED USING A 2.0 MM X 15 MM MINI TREK, BUT AT 6 ATM DURING THE FIRST INFLATION THE BALLOON RUPTURED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. A DIFFERENT SAME SIZE NON-ABBOTT BALLOON WAS USED AND A XIENCE V STENT WAS DEPLOYED. THOUGH REQUESTED, 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 1012962

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR GUIDE WIRE: INTERMEDIATE