BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2200024 · Received August 10, 2011

    Report

    Report Number
    2024168-2011-05659
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    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. GUIDING CATHETER: RADIGUIDE 6F JR3.5; GUIDE WIRE: WHISPER MS; STENT: XIENCE V 2.5X15. 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. ALTHOUGH RETURN OF THE VOYAGER NC MAY HAVE FURTHER AIDED THE INVESTIGATION, THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE AND THE DEVICE WAS SUCCESSFULLY USED FOR PRE-DILATATION, BOTH OF WHICH 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. IN THIS CASE, THE BALLOON MATERIAL LIKELY BECAME DAMAGED (SCRATCHED) FROM INTERACTIONS WITH OTHER DEVICES, THE STENT IMPLANT AND/OR THE TORTUOUS AND CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON INFLATION ATTEMPT. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, ALL DILATATION CATHETERS ARE 100% 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. 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. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT, THE REPORTED RUPTURE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE-DILATATION IN THE 90% STENOSED, HEAVILY CALCIFIED RIGHT CORONARY ARTERY WAS SUCCESSFULLY PERFORMED WITH A 2.5X8MM VOYAGER NC BALLOON. AFTER STENT PLACEMENT, THE STENTED LESION WAS POST-DILATED WITH THE SAME 2.5X8MM VOYAGER NC BALLOON, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 16 ATMOSPHERES. THERE WAS NO ADVERSE PATIENT SEQUELA AND A NEW VOYAGER NC BALLOON SUCCESSFULLY POST-DILATED THE STENTED LESION. THERE WAS NO ADDITIONAL INFORMATION 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 1021661

    Patients

    Seq Age Sex Outcome Treatment
    1