BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1961921 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00337
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 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 20 MM TAZUNA, 3.0 X 15 MM QUANTUM MAVERICK, 1.5 X 20 MM TAZUNA; GUIDE WIRE: FIELDER FC; STENT: CYPHER SELECT+. EVALUATION SUMMARY: EVALUATION OF THE RETURNED VOYAGER NC DILATATION CATHETER NOTED BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND ON THE HYPOTUBE SHAFT. THERE WAS ALSO BLOOD VISIBLE IN THE BALLOON, WHICH WAS LOOSELY FOLDED. THESE FINDINGS ARE CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND A LEAK OR BALLOON RUPTURE. AN ATTEMPT WAS MADE TO PRESSURIZE THE BALLOON AND THE ANALYSIS CONFIRMED THAT THERE WAS A PINHOLE IN THE BALLOON APPROXIMATELY 4 MM DISTAL TO THE PROXIMAL BALLOON MARKER. THERE WAS ALSO SHREDDING/PEELING OBSERVED ALONG THE ENTIRE LENGTH OF THE BALLOON. FACTORS THAT CAN CONTRIBUTE TO PINHOLES/TEARS AND BALLOON SHREDDING MAY INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, 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 MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ADDITIONALLY, THE LESION WAS MILDLY TORTUOUS, HEAVILY CALCIFIED AND 90% STENOSED, WHICH LIKELY CONTRIBUTED TO THE EXPERIENCED RUPTURE. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS CONFIRMED A RADIAL LEAK LOCATED ON THE BALLOON SURFACE, INTERSECTING A FOLD. THERE WAS ALSO MECHANICAL DAMAGE OBSERVED ALONG THE OUTER SURFACE ADJACENT TO THE LEAK. ADDITIONALLY, SHREDDING AND SCRATCHES WERE NOTED IN VARIOUS AREAS ALONG THE ENTIRE SURFACE OF THE BALLOON. THE SEM ANALYSIS ULTIMATELY DETERMINED THAT BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE ON THE OUTER SURFACE OF THE BALLOON. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE AT SOME POINT DURING THE PROCEDURE, THIS CAN CAUSE THE MATERIAL TO WEAKEN AND RUPTURE BELOW ITS RATED BURST PRESSURE (RBP)DURING AN ATTEMPT TO INFLATE THE CATHETER. 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. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THE ANALYSIS OF THE RETURNED PRODUCT AND THE RESULTS OF THE SEM ANALYSIS, THE REPORTED BALLOON RUPTURE AND DAMAGE NOTED APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A 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 RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC DE NOVO LESION, 90% STENOSED OF THE LEFT ANTERIOR DESCENDING ARTERY, THE FIELDER FC GUIDE WIRE WAS PLACED AND PRE-DILATATION COMPLETED WITH A 1.5 X 20 MM NON-ABBOTT BALLOON FOLLOWED BY DILATATION WITH THE 3.0 X 12 MM VOYAGER NC; HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERE FOR 5 SECONDS, THE BALLOON RUPTURED. A 3.0 X 15 MM NON-ABBOTT BALLOON WAS USED WITH A NON-ABBOTT STENT BUT COULD NOT CROSS THE LESION. THERE WAS NO REPORTED PATIENT EFFECT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DEVICE ANALYSIS REVEALED BALLOON PEELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 9070961

    Patients

    Seq Age Sex Outcome Treatment
    1