BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2221125 · Received August 23, 2011

    Report

    Report Number
    2024168-2011-05926
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 30, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED MINI TREK DILATATION CATHETER NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN A LOOSELY FOLDED BALLOON CONSISTENT WITH PREPARATION. AN INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE BALLOON AND FLUID WAS OBSERVED LEAKING AT A PINHOLE IN THE BALLOON OVER THE DISTAL MARKER, CONFIRMING THE REPORTED RUPTURE. THERE WERE NO SCRATCHES VISIBLE. 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. SCANNING ELECTRON MICROSCOPY (SEM) NOTED THE BALLOON FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. DAMAGE WAS OBSERVED AT AND LEADING TO THE SITE OF THE LEAK. 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. THE PATIENT ANATOMY WAS MODERATELY CALCIFIED WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. HOWEVER, IT IS POSSIBLE THAT THE BALLOON WAS DAMAGED DURING MANUFACTURING SUCH THAT UPON THE INFLATION ATTEMPT, THE BALLOON RUPTURED AS A RESULT OF THE DAMAGE, THOUGH THIS CANNOT BE CONFIRMED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY BURST PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY TORTUOUS AND CALCIFIED, ECCENTRIC 95% STENOSED DE NOVO, RIGHT CORONARY ARTERY LESION, THE NON-ABBOTT GUIDE WIRE CROSSED AND PREDILATATION WAS ATTEMPTED WITH THE 2.0 X 15 MM MINI TREK; HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERE (ATM), FOR LESS THAN 10 SECONDS THE BALLOON RUPTURED. A NON-ABBOTT BALLOON WAS USED TO PREDILATE AT 16 ATM AND A 3.0 X 23 MM AND A 3.5 X 15 MM XIENCE V STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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