BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1935939 · Received December 22, 2010

    Report

    Report Number
    2024168-2010-02857
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DILATATION CATHETER: 1.5 X 15 MM RX VOYAGER (1011391-15/9051441), 1.5 X 15 MM TAZUNA, 2.0 X 15 MM TAZUNA; GUIDE WIRE: SION BLUE(SJM). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. THE 1.5 X 15 MM RX VOYAGER ((B)(4)), IS BEING FILED UNDER A SEPARATE MFR#.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED VOYAGER RX DILATATION CATHETER NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH PREPARATION. THE BALLOON WAS LOOSELY FOLDED. THERE WAS A KINK IN THE SHAFT 2 CM PROXIMAL TO THE PROXIMAL BALLOON MARKER. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINK MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON WHEN FLUID WAS OBSERVED LEAKING OUT OF A LONGITUDINAL RUPTURE IN THE BALLOON 1 MM DISTAL FROM THE DISTAL BALLOON MARKER EXTENDING PROXIMALLY FOR A LENGTH OF 6 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 THAT THE RUPTURE MAY POSSIBLY BE RELATED TO EXPOSURE CONDITIONS OR A MATERIAL/PROCESSING DISCREPANCY. THE BALLOON FAILURE INITIATED ALONG THE INNER SURFACE AND DID NOT APPEAR TO BE ALONG A FOLD OR CREASE. LONGITUDINAL LINES AND PARTIAL TEARING WERE OBSERVED ALONG THE INNER SURFACE ADJACENT TO THE FRACTURE. NO EVIDENCE OF SCRATCHES ASSOCIATED WITH THE FAILURE WAS OBSERVED. BALLOON RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT 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. THE RUPTURE INITIATED ALONG THE INNER SURFACE WHICH IS CONSISTENT WITH MULTIPLE AND HIGH PRESSURE INFLATIONS SUCH THAT THE BALLOON RUPTURED BELOW THE RATED BURST PRESSURE (RBP) OF 14 ATMOSPHERES. 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. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 1.5 X 15 MM VOYAGER RX BALLOON RUPTURED. THE LESION WAS THEN DILATED WITH A NON-ABBOTT BALLOON CATHETER. A 2.0 X 12 VOYAGER RX WAS USED IN AN ATTEMPT TO PREDILATE FURTHER; HOWEVER, THIS BALLOON ALSO RUPTURED UPON INFLATION. THE LESION WAS FURTHER DILATED WITH A NON-ABBOTT BALLOON CATHETER, AND A XIENCE V STENT WAS IMPLANTED. NO ADDITIONAL INFORMATION OR PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0032362

    Patients

    Seq Age Sex Outcome Treatment
    1