BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2024348 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01847
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR BALLOON RUPTURES FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. TO ENSURE THIS IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE. RETURN OF THE VOYAGER NC CATHETER USED IN THE PROCEDURE MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH MAY SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH ACCESSORY DEVICES, OR THE LESION/ANATOMY, SUCH THAT THE BALLOON RUPTURED UPON THE INFLATION AT AN UNKNOWN PRESSURE. WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED.

    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. THE OTHER VOYAGER NC CORONARY DILATATION CATHETER IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH VOYAGER NC DEVICES RUPTURED; HOWEVER, THE ATMOSPHERES ARE UNKNOWN. BOTH DEVICES WERE PREPPED PER PACKAGE INSERT. THE CASE INVOLVED THE RIGHT CORONARY ARTERY WITH NO CALCIFICATION AND NO TORTUOSITY; DE NOVO LESION. EVEN THOUGH THE DEVICES RUPTURED, THERE WAS SOME DILATATION ACCOMPLISHED AND A STENT WAS DEPLOYED WITH NO ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO PATIENT INJURY. 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 0093061

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR