BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1060747 · Received June 11, 2008

    Report

    Report Number
    2024168-2008-00474
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 12, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVALUATION OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITH BLOOD VISIBLE IN THE BALLOON. THERE WAS CONTRAST VISIBLE ON THE HYPOTUBE AND IN THE INFLATION LUMEN. THE BALLOON WAS LOOSELY FOLDED. THERE WAS A KINK IN THE SHAFT 2 MM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER WHEN FLUID LEAKED OUT OF A CRACK IN THE PROXIMAL END OF THE HUB 8MM IN LENGTH. A DISSECTION WAS PERFORMED TO BYPASS THE CRACK IN THE HUB. THERE WERE TWO RADIAL TEARS IN THE BALLOON 3MM AND 4MM DISTAL TO THE PROXIMAL BALLOON MARKER. THE DEVICE WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVALUATION OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE LESION #3 HAD MILD TORTUOSITY AND WAS WITH 99% STENOSIS. THE VOYAGER RX BALLOON CATHETER WAS DELIVERED TO THE LESION AND DILATED FIRST AT 8 ATM FOR 30 SECONDS. THEN, THE BALLOON WAS INFLATED FOR THE SECOND TIME AT 12 ATM FOR 5 SECONDS, WHEN THE BALLOON RUPTURED. THE BALLOON CATHETER WAS REPLACED WITH A 2.5X15MM BALLOON CATHETER FROM ANOTHER COMPANY AND THE LESION WAS DILATED AT 12 ATM FOR 30 SECONDS. THE PROCEDURE WAS COMPLETED AFTER DEPLOYING A 3.0X18MM VISION STENT. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7101531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRE: RUNTHROUGH| GUIDE CATH: HEARTRAIL| DIL CATH: LACROSSE 2.5-15| STENT: VISION 3.0-18