BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2131909 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04279
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND A RUPTURE/LEAK WHILE IN THE PATIENT ANATOMY. THE BALLOON WAS LOOSELY FOLDED. THERE WERE TWO BENDS IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. AN INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE BALLOON WHEN FLUID WAS OBSERVED LEAKING FROM A FLAP RUPTURE IN THE BALLOON OVER THE DISTAL MARKER. BALLOON RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH THE STENT OR OTHER DEVICES, PATIENT ANATOMY, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% LEAK TESTED ON LINE AND A SAMPLING OF UNITS ARE RUPTURE TESTED PRIOR TO RELEASE. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS SUGGESTS THAT THE BALLOON WAS NOT LIKELY DAMAGED PRIOR TO USE. ANALYSIS NOTED A FLAP OF TORN BALLOON MATERIAL OVER THE DISTAL BALLOON MARKER. DAMAGE OF THIS TYPE CAN BE THE RESULT OF MATERIAL PROCESSING OR INCORRECT PREPARATION FOR USE. FOLLOW UP INFORMATION RECEIVED FROM THE ACCOUNT CONFIRMED THAT THE BALLOON WAS NOT SOAKED PRIOR TO USE. IT SHOULD BE NOTED THE RX MINI TREK INSTRUCTIONS FOR USE STATES TO SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. IT IS LIKELY 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 SIMILAR INCIDENTS REPORTED FOR INFLATION ISSUES OR BALLOON MATERIAL RUPTURES FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTY INFLATING THE BALLOON AND NOTED BALLOON RUPTURE APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION. AN ATHERECTOMY DEVICE WAS USED, AND THE MINI TREK BALLOON WAS ADVANCED TO THE LESION; HOWEVER, THE BALLOON WOULD NOT INFLATE. IT WAS NOTED THAT THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL. ANOTHER MINI TREK BALLOON WAS USED SUCCESSFULLY AND A XIENCE V STENT WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS. IT WAS FURTHER NOTED THAT THE MINI TREK BALLOON WAS NOT SUBMERGED IN SALINE DURING DEVICE PREPARATION. 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 1031562

    Patients

    Seq Age Sex Outcome Treatment
    1