BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2080891 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03277
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: EVALUATION OF THE RETURNED CATHETER FOUND BLOOD VISIBLE ON THE TIP, THE SHAFT AND IN THE INFLATION LUMEN, SUGGESTING THAT THE DEVICE WAS ADVANCED INSIDE THE BODY WHICH IS CONSISTENT WITH A LEAK OR BALLOON RUPTURE. THE BALLOON WAS STILL TIGHTLY-FOLDED, INDICATING THAT THE BALLOON WAS NOT ABLE TO BE PRESSURIZED UPON INFLATION. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER AND THE ANALYSIS CONFIRMED THE REPORTED COMPLAINT AS FLUID LEAKED FROM A LONGITUDINAL RUPTURE IN THE BALLOON ABOVE THE DISTAL MARKER. SCANNING ELECTRON MICROSCOPY (SEM) REVEALED TWO LONGITUDINAL RUPTURES IN THE BALLOON ABOVE THE DISTAL MARKER. THE LEAKS WERE ADJACENT TO ONE ANOTHER, ONE IN A FOLD/CREASE AND THE OTHER OUTSIDE OF A FOLD. ADDITIONALLY, THERE WERE LONGITUDINAL LINES AND DAMAGE FOUND ADJACENT AND DISTAL TO THE LEAKS ON THE OUTER SURFACE. ON THE INNER SURFACE OF THE BALLOON, THE RUPTURES WERE OBSERVED AT THE DISTAL MARKER IMPRESSION WITH DAMAGE NOTED ADJACENT TO THE LEAKS. THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. 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 AND MARKER WERE DAMAGED/PINCHED DURING MANUFACTURING SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED AS A RESULT OF THE DAMAGE, THOUGH THIS CANNOT BE CONFIRMED. 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, THERE WAS NO CALCIFICATION OR TORTUOSITY IN VESSEL/LESION, WHICH MAY SUGGEST THAT THE PATIENT ANATOMY DID NOT CONTRIBUTE TO THE EXPERIENCED RUPTURE. 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 FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. A DEFINITIVE CAUSE FOR THE RUPTURES/LEAKS IN THE BALLOON COULD NOT BE DETERMINED. 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 BURTS PRESSURE (RBP) AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT ANTERIOR DESCENDING ARTERY STENTING PROCEDURE, THE TREK BALLOON DILATATION CATHETER WAS EASILY ADVANCED TO THE LESION; HOWEVER, UPON INFLATION, THE BALLOON LOST PRESSURE AT 4-5 ATMOSPHERES (ATM). THE BALLOON DILATION CATHETER WAS REMOVED AND THE BALLOON RUPTURE WAS CONFIRMED OUTSIDE OF THE BODY. A NON-ABBOTT DEVICE WAS USED SUCCESSFULLY TO DILATE THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0100561

    Patients

    Seq Age Sex Outcome Treatment
    1