BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2131461 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04252
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 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. PHYSICAL RESISTANCE DURING ADVANCEMENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE CATHETER, AND INTERACTIONS WITH OTHER DEVICES OR ACCESSORY DEVICE SUPPORT. BASED ON THE INFORMATION PROVIDED, THE LESION WAS MODERATELY TORTUOUS, HEAVILY CALCIFIED AND 99% STENOSED, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTY. FURTHERMORE, BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. IN THIS CASE, SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. IT IS POSSIBLE THAT THE BALLOON MATERIAL BECAME DAMAGED (SCRATCHED) FROM INTERACTIONS WITH OTHER DEVICES AND/OR THE TORTUOUS AND CALCIFIED LESION AS RESISTANCE WAS ENCOUNTERED, SUCH THAT THE BALLOON RUPTURED UPON INFLATION ATTEMPT. ULTIMATELY, RETURN OF THE MIN TREK MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED RUPTURE. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL 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. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL ON-LINE INSPECTIONS AND TESTING MET MANUFACTURING CRITERIA. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. BASED ON THE INFORMATION RECEIVED WITH THIS EVENT, THE REPORTED DIFFICULTY CROSSING/PHYSICAL RESISTANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. HOWEVER, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISTAL CIRCUMFLEX STENTING PROCEDURE, RESISTANCE WAS FELT DURING ADVANCEMENT OF THE 2.0 X 20MM MINI TREK BALLOON DUE TO THE HEAVY CALCIFICATION. DURING THE FIRST INFLATION, THE MINI TREK BALLOON RUPTURED AT 14 ATMOSPHERES. A XIENCE STENT WAS SUCCESSFULLY IMPLANTED AND THE LESION WAS POST-DILATED WITH A NON-ABBOTT BALLOON. THERE WAS NO ADVERSE PATIENT SEQUELA. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 0080561

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR