BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1163386 · Received September 10, 2008

    Report

    Report Number
    2024168-2008-00780
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 9, 2008
    Report Date
    August 11, 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 AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, INTERACTIONS WITH OTHER DEVICES, PATIENT ANATOMY, LESION CALCIFICATION AND TORTUOSITY. IN THIS CASE, THE LESION WAS MODERATELY TORTUOUS AND CALCIFIED WITH 75% STENOSIS AND RESTENOSIS IN A PREVIOUSLY IMPLANTED STENT, WHICH MAY HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED. IT IS POSSIBLE THAT THE BALLOON WAS DAMAGED DURING INTERACTIONS WITH THE STENT OR THE TORTUOUS AND CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON INFLATION. WITHOUT A RETURNED DEVICE FOR ANALYSIS, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE TARGET LESION WAS THE DISTAL RCA WITH MODERATE TORTUOSITY MILD CALCIFICATION AND 75% STENOSIS. THE VESSELS HAD RESTENOSIS FROM ANOTHER COMPANY'S STENT THAT WAS IMPLANTED THREE MONTHS PREVIOUSLY. THE VOYAGER WAS DELIVERED AND INFLATED AT THE LESION, HOWEVER, IT RUPTURED DURING THE SECOND INFLATION AT 14 ATM. THERE WERE NO PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 8013031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DILATATION CATHETER: 2.5 X 8 MM QUANTUM MAVERICK| GUIDING CATHETER: HEARTRAIL JR4| STENT: 2.5 X 13 MM CYPHER| GUIDE WIRE: ATHLETE GT