BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 1913455 · Received November 12, 2010

    Report

    Report Number
    2024168-2010-02442
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED MINI TREK DILATATION CATHETER NOTED BLOOD VISIBLE IN THE BALLOON, INFLATION LUMEN AND ON THE HYPOTUBE AND CONTRAST ON THE BALLOON. THE BALLOON WAS LOOSELY FOLDED. THIS IS CONSISTENT WITH PREPARATION AND A LEAK OR RUPTURE WHILE IN THE PATIENT ANATOMY. THERE WERE MULTIPLE KINKS IN THE SHAFT 3 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH, FOR A LENGTH OF 6.5 CM. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINKS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON TO THE RATED BURST PRESSURE (RBP) OF 14 ATMOSPHERE (ATM), WHEN IT WAS OBSERVED THAT FLUID WAS COMING OUT A LONGITUDINAL RUPTURE IN THE BALLOON 1 MM PROXIMAL FROM THE PROXIMAL BALLOON MARKER AND EXTENDING DISTALLY, FOR AN OVERALL LENGTH OF 3 MM. THERE WERE NO SCRATCHES FOUND AND IT COULD NOT BE DETERMINED IF THE RUPTURE WAS ALONG A CREASE OR FOLD IN THE BALLOON. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS DETERMINED THE BALLOON RUPTURE MAY POSSIBLY BE RELATED TO EXPOSURE CONDITIONS OR A MATERIAL/PROCESSING DISCREPANCY. RADIAL PEELING/DELAMINATION AT THE PROXIMAL MARKER RESULTED IN WALL THINNING AND THE RUPTURE. THE RUPTURE PROPAGATED LONGITUDINALLY IN BOTH DIRECTIONS FROM THE RADIAL FLAP. BALLOON RUPTURE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PATIENT ANATOMY, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. 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. AN INTERACTION WITH OTHER DEVICES AND/OR THE LESION MAY HAVE DAMAGED (SCRATCHED) AND WEAKENED THE BALLOON MATERIAL, SUCH THAT THE BALLOON RUPTURED UPON INFLATION AT 8 ATM, WHICH IS BELOW THE RBP OF 14 ATM. 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. A CONCLUSIVE CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON DILATATION CATHETER RUPTURED DURING INFLATION AT 8 ATMOSPHERES (ATM). DURING PRE-DILATATION OF A NEWLY UNBLOCKED CHRONIC TOTALLY OCCLUDED, HEAVILY CALCIFIED, PROXIMAL LEFT ANTERIOR DESCENDING (LAD) LESION, A NON-ABBOTT BALLOON WAS USED FOLLOWED BY THE MINI TREK. IT HAD BEEN PREPARED USING A SYRINGE PRIOR TO USE. AFTER BALLOON RUPTURE, A NON-ABBOTT BALLOON WAS USED AND THE PROCEDURE WAS CONTINUED WITHOUT ISSUE. THERE WAS NO REPORTED PT EFFECT. 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 ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0061962

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR DILATION CATHETER: NIC NANO 1.1X12| MAVERICK| GUIDE WIRE: GREAHIX PT| INFLATION: BSC