BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2083264 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03346
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 15, 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: FIELDER FC; GUIDE CATH: RADIGUIDE 6F JR3.5; STENT: 3.5 X 20 MM LIBERTY. 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. IN THIS CASE, RETURN OF THE BALLOON CATHETER MAY HAVE FURTHER AIDED THE INVESTIGATION. HOWEVER, SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE AND THE CATHETER WAS INITIALLY PRESSURIZED ONCE WITHOUT INCIDENT, THIS INDICATES THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. THE LESION WAS ALSO REPORTED AS MILDLY 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 SECOND INFLATION ATTEMPT. 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 FOR A BALLOON RUPTURE FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. 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. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. 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 RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS MODERATELY TORTUOUS, HEAVILY CALCIFIED WITH A 90% STENOSIS, IN THE DISTAL RIGHT CORONARY ARTERY. AFTER PRE-DILATATION OF THE LESION WITH A 3.0 X 10 MM NON-ABBOTT BALLOON CATHETER, A 3.5 X 20 MM NON-ABBOTT STENT WAS IMPLANTED. AFTER PERFORMING INTRAVASCULAR ULTRASOUND, THE STENT IMPLANT WAS FOUND NOT FULLY DILATED. THE 3.5 X 08 MM VOYAGER NC WAS USED FOR POST-DILATATION OF THE IMPLANTED STENT; HOWEVER, DURING THE SECOND INFLATION THE VOYAGER NC BALLOON RUPTURED AT 16 ATMOSPHERES. THE STENT WAS FURTHER DILATED WITH A 3.5 X 15 MM NON-ABBOTT BALLOON CATHETER AT 20 ATMOSPHERES. NO 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 0063061

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 FOR CONCOMITANT MEDICAL DEVICES