BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2810302 · Received October 31, 2012

    Report

    Report Number
    2024168-2012-06870
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: BMW/RUNTHROUGH, GUIDE CATHETER: 6FR EBU 3.5, RHV: MERIT, SHEATH: 6FR. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED PHYSICAL RESISTANCE AND DIFFICULTY TO REMOVE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. IN THIS CASE, THERE WAS NO REPORTED ISSUE WITH DEFLATION. IT IS LIKELY THAT THE CONTRAST INSIDE THE INFLATION LUMEN MAY HAVE SOLIDIFIED SUCH THAT IT RESULTED IN THE NOTED BALLOON NOT DEFLATING. ADDITIONALLY, INFORMATION WAS RECEIVED CONFIRMING THERE WAS NO DEFLATION ISSUE DURING THE PROCEDURE, THUS THERE IS NO INDICATION TO SUGGEST A DEFLATION PRODUCT ISSUE RELATED TO DEFLATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED AND AN ANALYSIS OF THE RETURNED DEVICE, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A 4.0X8 VOYAGER NC BALLOON DILATATION CATHETER (BDC), WAS ADVANCED TO A HEAVILY CALCIFIED, 95% STENOSED LESION IN THE HEAVILY TORTUOUS PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY, WITH RESISTANCE FELT. UPON INFLATING THE VOYAGER NC BALLOON, WHILE THE BALLOON WAS ABLE TO BE INFLATED WITHOUT ISSUE, THE LESION WAS NOT ABLE TO BE COMPLETELY DILATED DUE TO HEAVY CALCIFICATION. THE VOYAGER WAS WITHDRAWN FROM THE ANATOMY WITH RESISTANCE FELT, AND A NON-ABBOTT BDC WAS ABLE TO SUCCESSFULLY CROSS THE LESION. THE FINAL PROCEDURE RESULT YIELDED 0% STENOSIS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. ALTHOUGH THERE WERE REPORTEDLY NO DEFLATION ISSUES AND THE CORRECT COMPLAINT DEVICE WAS RETURNED, ADDITIONAL TESTING BY THE RETURNED GOODS LAB REVEALED A FAILURE TO DEFLATE THE BALLOON. 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 0110961

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR