BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2152584 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04806
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 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. 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, INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. 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 PRESSURIZED ONCE WITHOUT INCIDENT, THIS INDICATES THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. THE LESION WAS ALSO CHARACTERIZED AS BEING MILDLY TORTUOUS AND 90% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. THE BALLOON MATERIAL LIKELY BECAME DAMAGED (SCRATCHED) FROM INTERACTIONS WITH OTHER DEVICES AND/OR THE PATIENT ANATOMY, SUCH THAT THE BALLOON RUPTURED DURING A SECOND INFLATION. 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 THE RATED BURST PRESSURE (RBP) AND BALLOON INTEGRITY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL ON-LINE INSPECTIONS AND TESTING MET MANUFACTURING CRITERIA. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED 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 CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE-DILATATION WAS PERFORMED WITH THE VOYAGER NC BALLOON CATHETER IN THE DISTAL LEFT CIRCUMFLEX ARTERY. UPON SECOND INFLATION, THE BALLOON RUPTURED AT 8 TO 9 ATMOSPHERES. VESSEL AND LESION SITE WERE CHARACTERIZED AS BEING MILDLY TORTUOUS, NON-CALCIFIED, ECCENTRIC, DE NOVO AND 90% STENOSED. 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 0062863

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RINATOGUIDE CATH: MACH 1