BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 1980772 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00739
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, PATIENT ANATOMY, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ALTHOUGH NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED, IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH THE STENT IMPLANT, THE LESION AND/OR OTHER DEVICES SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED. ULTIMATELY, RETURN OF THE PRODUCT MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED RUPTURE. REPORTEDLY, THE CATHETER WAS PRESSURIZED ABOVE RPB TO 26 ATMOSPHERES. IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE WARNS: BALLOON PRESSURE SHOULD NOT EXCEED THE RBP. USE OF A PRESSURE-MONITORING DEVICE IS RECOMMENDED TO PREVENT OVERPRESSURIZATION. IN THIS CASE, INFLATING THE BALLOON CATHETER BEYOND ITS SPECIFIED RBP MAY HAVE CONTRIBUTED TO THE EXPERIENCED RUPTURE. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THE REPORTED BALLOON RUPTURE MAY HAVE BEEN RELATED TO OPERATIONAL CONTEXT OF THE DEVICE; HOWEVER, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE CANNOT BE DETERMINED. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL MANUFACTURING OR PRODUCT RELATED DEFICIENCY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PLACING A 2.75 X 38 MM XIENCE PRIME IN THE LEFT ANTERIOR DESCENDING ARTERY, TREATMENT OF THE SIDE BRANCH/FIRST DIAGONAL COULD NOT BE PERFORMED BECAUSE OF TRYING TO CROSS THROUGH THE PREVIOUSLY PLACED STENT STRUTS WITH THE 2.25 X 23 MM XIENCE PRIME. THE SIDE BRANCH WAS REWIRED, BUT AFTER SEVERAL TRIES WITH DIFFERENT BALLOONS A 2.0 X 15 MM MINI TREK CROSSED AND WAS INFLATED TO 26 ATMOSPHERES RESULTING IN BALLOON RUPTURE. ANOTHER ATTEMPT WAS MADE TO CROSS WITH A NON-ABBOTT BALLOON CATHETER TO WIDEN THE SIDE HOLE FAILED. AN ATTEMPT WAS MADE TO PLACE A 2.25 X 8 MM XIENCE PRIME THROUGH THE STENT STRUTS; HOWEVER, THIS FAILED. FINALLY THE PROCEDURE WAS FINISHED WITHOUT ANY BALLOONING OR PLACING A STENT IN THE FIRST DIAGONAL BRANCH. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR