BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2162877 · Received July 15, 2011

    Report

    Report Number
    2024168-2011-04969
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED VOYAGER NC BALLOON CATHETER FOUND THAT THE BALLOON WAS LOOSELY-FOLDED, SUGGESTING THAT THE DEVICE WAS PRESSURIZED DURING THE PROCEDURE. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER AND THE ANALYSIS CONFIRMED THAT THERE WAS A PINHOLE IN THE BALLOON ABOVE THE DISTAL MARKER. ADDITIONALLY, THERE WAS A LONGITUDINAL SCRATCH ADJACENT TO THE PINHOLE, SUGGESTING THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE OF THE BALLOON. AS THERE WAS NO REPORT OF ANY LEAK NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. THE LESION WAS ALSO CHARACTERIZED AS MODERATELY CALCIFIED AND LIKELY CONTRIBUTED TO THE REPORTED RUPTURE. IN THIS CASE, THE BALLOON MATERIAL LIKELY BECAME DAMAGED (SCRATCHED) AND WEAKENED FROM AN INTERACTION WITH OTHER DEVICES, THE STENT IMPLANT AND/OR THE CALCIFIED LESION, SUCH THAT IT RUPTURED UPON INFLATION ATTEMPT. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, PATIENT ANATOMY, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND THE ANALYSIS OF THE RETURNED PRODUCT, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY. 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. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY CALCIFIED, PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, THE VOYAGER NC BALLOON WAS USED FOR POST DILATATION OF A NON-ABBOTT STENT. WHILE INFLATING THE BALLOON TO 10 ATMOSPHERE BLOOD WAS NOTED IN THE BALLOON; THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT INCIDENT. AFTER REMOVAL A HOLE WAS NOTED IN THE CATHETER BALLOON. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1022561

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR