BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1081669 · Received July 24, 2008

    Report

    Report Number
    2024168-2008-00602
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    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 COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE BALLOON. THE BALLOON HAD LOOSE FOLDS. THE INNER MEMBER WAS SEPARATED 1.2 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH, THERE WAS A GAP BETWEEN THE TWO PIECES OF INNER MEMBER FOR A LENGTH OF 2 MM. THE SEPARATED EDGES OF THE INNER MEMBER WERE STRETCHED. THE INNER MEMBER WAS NOT BUNCHED. THERE WAS NO DAMAGE NOTED TO THE OUTER MEMBER. THE INFLATION DEVICE USED IN THE PROCEDURE WAS NOT RETURNED. THE TOTAL CATHETER LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE DISTAL CATHETER LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE BALLOON CATHETER, WHEN FLUID LEAKED FROM THE GUIDE WIRE EXIT NOTCH. THE BALLOON DID NOT INFLATE, DUE TO THE LEAK IN THE GUIDE WIRE EXIT NOTCH. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS 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/LEAK IN SHAFT. DEVICE ISSUE: LEAK IN SHAFT. IT WAS REPORTED THAT THE TARGET LESION WAS IN THE FIRST DIAGONAL WITH MILD TORTUOSITY MILD CALCIFICATION, AND 90% STENOSIS. AFTER PERFORMING IVUS, THE VOYAGER 3.5 X 15 MM WAS DELIVERED AND INFLATED AT 8 ATM. HOWEVER, AT THE SECOND INFLATION, THE PRESSURE ONLY WENT UP TO 2 ATM, AND WENT DOWN. WHEN THE LESION WAS CONFIRMED OVER THE ANGIOGRAM, A DISSECTION HAD OCCURRED AT THE LESION. A NEW VOYAGER 3.5 X 15 MM WAS DELIVERED AND IT WAS INFLATED SEVERAL TIMES. THE STENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. WHEN THE VOYAGER WAS INFLATED OUTSIDE THE PATIENTS BODY AGAIN, THERE WERE LEAKS FROM THE TIP AND AROUND THE GUIDE WIRE EXIT PORT (TWO PARTS). 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 7110831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GUIDE WIRE BALANCE| GUIDE CATH: BRITE TIP JL4| STENT DRIVER 3.5X12