BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2152524 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04804
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED TREK BALLOON CATHETER NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE LOOSELY-FOLDED BALLOON, WHICH SUGGESTS THAT THE DEVICE WAS PREPARED FOR USE AND AN ATTEMPT WAS MADE TO PRESSURIZE THE CATHETER. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER, THERE WAS A PINHOLE IN THE BALLOON ABOVE THE DISTAL MARKER. THERE WERE NO VISIBLE SCRATCHES. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIAL DEFICIENCIES, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, LESION CALCIFICATION AND TORTUOSITY OR INSUFFICIENT PREPARATION PRIOR TO USE. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS CONCLUDED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE LEAK WAS ALONG A FOLD CREASE OVER THE DISTAL MARKER. THERE WAS ALSO A SLIGHT RIDGE OBSERVED IN THE DISTAL MARKER. NO LEAKS WERE REPORTED DURING PREPARATION FOR USE, WHICH MAY INDICATE THAT THE RUPTURE WAS NOT PRESENT PRIOR TO THE PROCEDURE. THE LESION WAS ALSO HEAVILY CALCIFIED AND MAY HAVE CONTRIBUTED TO THE REPORTED RUPTURE; HOWEVER, BASED ON THE REVIEW OF THE SEM IMAGES, IT IS POSSIBLE THAT THE BALLOON AND MARKER WERE DAMAGED/PINCHED DURING MANUFACTURING SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED AS A RESULT OF THE DAMAGE, THOUGH THIS COULD NOT BE CONFIRMED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS NOT SOAKED PRIOR TO USE. IT SHOULD BE NOTED THAT THE TREK INSTRUCTIONS FOR USE STATES: SUBMERGE THE BALLOON IN HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. THE FAILURE TO SOAK THE BALLOON PRIOR TO USE MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE; HOWEVER, THIS COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMR) ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT ALL LOT RELEASE TESTING MET SPECIFICATION. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TREK BALLOON RUPTURED DURING THE FIRST INFLATION AT 9 ATMOSPHERES IN THE HEAVILY CALCIFIED LESION. THERE WAS NO REPORTED RESISTANCE DURING ADVANCEMENT OR RETRACTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT BALLOON CATHETER. NO 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 0100862

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR