BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2060205 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02676
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CATHETER WAS RETURNED WITH BLOOD VISIBLE ON THE HYPOTUBE SHAFT AND ON THE LOOSELY-FOLDED BALLOON, WHICH IS CONSISTENT WITH HANDLING AND THE REPORTED USE OF THE DEVICE. THERE WAS ALSO CONTRAST VISIBLE IN THE INFLATION LUMEN, SUGGESTING THAT THE DEVICE WAS PREPARED FOR USE. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER WHEN FLUID LEAKED FROM TWO PINHOLES IN THE BALLOON ABOVE THE DISTAL MARKER, CONFIRMING THE REPORTED RUPTURE. BOTH PINHOLES WERE 0.5MM IN LENGTH. SCANNING ELECTRON MICROSCOPY (SEM) CONCLUDED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE LEAKS WERE LOCATED ALONG A FOLD/CREASE IN THE BALLOON JUST PROXIMAL TO THE DISTAL MARKER. IN THIS CASE, THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, WHICH MAY INDICATE THAT THE RUPTURE WAS NOT PRESENT PRIOR TO THE PROCEDURE. HOWEVER, IT IS POSSIBLE THAT THE BALLOON WAS DAMAGED/PINCHED DURING MANUFACTURING SUCH THAT UPON 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 AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR A BALLOON RUPTURE FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. 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. REPORTEDLY, THE LESION WAS NOT CALCIFIED OR TORTUOUS, WHICH MAY SUGGEST THAT THE PATIENT ANATOMY DID NOT CONTRIBUTE TO THE EXPERIENCED RUPTURE. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    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 RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IN A PROXIMAL TO MID CIRCUMFLEX LESION, THE BALLOON RUPTURED WHEN INFLATED TO 14 ATMOSPHERES. THE VESSEL WAS NOT NOTED TO BE CALCIFIED OR TORTUOUS. ANOTHER TREK OF THE SAME SIZE WAS USED WITHOUT ISSUE TO SUCCESSFULLY TREAT THE LESION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0102861

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR