BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2080771 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03270
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 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. GUIDE WIRE: SION BLUE. GUIDE CATH: HEARTRAIL 7F IR. STENT: XIENCE 3.5 X 28. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE 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. IN THIS CASE, THE RETURN OF THE BALLOON CATHETER MAY HAVE AIDED THE INVESTIGATION. HOWEVER, SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE AND THE CATHETER WAS INITIALLY PRESSURIZED TWICE WITHOUT INCIDENT, THIS INDICATES THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. THE LESION WAS REPORTED AS MODERATELY TORTUOUS, MODERATELY CALCIFIED AND 90% STENOSED, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTY. THE BALLOON MATERIAL LIKELY BECAME DAMAGED (SCRATCHED) FROM INTERACTIONS WITH OTHER DEVICES, THE IMPLANTED STENT AND/OR THE TORTUOUS AND CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON A THIRD INFLATION ATTEMPT. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, 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. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE DEVICE 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. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. PRE-DILATATION WAS PERFORMED WITH A TREK BALLOON, AND A XIENCE V STENT WAS IMPLANTED. AFTER INTRAVASCULAR ULTRA SOUND (IVUS), IT WAS DECIDED THAT FURTHER STENT INFLATION WAS NEEDED; THEREFORE, POST-DILATATION WAS PERFORMED WITH THE VOYAGER NC BALLOON; HOWEVER, DURING THE THIRD INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 0090161

    Patients

    Seq Age Sex Outcome Treatment
    1