BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER? RX CORONARY DILATION CATHETER

    MDR report key: 1313825 · Received February 16, 2009

    Report

    Report Number
    2024168-2009-00249
    Event Type
    Injury
    Date Received
    February 16, 2009
    Date of Event
    January 16, 2009
    Report Date
    January 20, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 PERFORM AN EVALUATION AT THE TIME OF THE REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETUNED WITH BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE BALLOON. THERE WAS THICK CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE BALLOON. THE BALLOON HAD LOOSE FOLDS. THERE WERE NO KINKS NOTED TO THE INNER MEMBER OR THE TIP. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE INFLATION DEVICE USED IN THE PROCEDURE WAS NOT RETURNED. A NEW INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE BALLOON CATHETER TO 12 ATM AND NOTED THERE WAS NO FLUID ADVANCING THROUGH THE CATHETER, DUE TO THE THICK CONTRAST. THE BALLOON CATHETER WAS LEFT PRESSURIZED AT 12 ATM FOR 3 HOURS TO DISSOLVE THE CONTRAST. THE CONTRAST DID DISSOLVE AND A LONGITUDINAL RUPTURE WAS NOTED AT THE DISTAL END OF THE DISTAL TAPER AND EXTENDING PROXIMALLY FOR A LENGTH OF 1.1 CM. THERE WERE NO SCRATCHES VISIBLE ON THE BALLOON. THE VOYAGER WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO PERFORM AN EVALUATION AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE TARGET LESION WAS THE DISTAL RCA WITH NO TORTUOSITY, NO CALCIFICATION. THE PATIENT WAS PRESENTED WITH SUB ACUTE THROMBOSIS THAT OCCURRED AROUND THREE STENTS FROM ANOTHER COMPANY IMPLANTED A WEEK BEFORE THIS PCI PROCEDURE. THE VOYAGER RX BALLOON CATHETER WAS DELIVERED TO THE LESION. THEN, THE BALLOON WAS INFLATED TO 6 ATM AND THE BALLOON RUPTURED. A DISSECTION OCCURRED DUE TO THE RUPTURE. THE LESION WAS FURTHER DILATED USING ANOTHER COMPANY'S BALLOON TO TREAT THE DISSECTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER? RX CORONARY DILATION CATHETER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8072941

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GUIDE CATH: HEARTRAIL 6F| OTHER: IVUS VOLCANO| GUIDE WIRE: SUOH| STENT: 2.5 X 23 MM CYPHER| DILATION CATHETER: 2.0 X 20 MM APEX