BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER? RX CORONARY DILATATION CATHETER

    MDR report key: 1172334 · Received September 19, 2008

    Report

    Report Number
    2024168-2008-00824
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 21, 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

    EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITH BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, INFLATION LUMEN, AND BALLOON. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS TIGHTLY FOLDED. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON CATHETER WHEN FLUID LEAKED OUT OF A LONGITUDINAL RUPTURE OVER THE PROXIMAL BALLOON MARKER FOR A LENGTH OF 2 MM. THERE WAS A LONGITUDINAL SCRATCH PROXIMAL TO THE RUPTURE FOR A LENGTH OF 2.5 MM. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND THE RETURNED DEVICE ANALYSIS. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PT ANATOMY, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. REPORTEDLY, THE LESION WAS MILDLY TORTUOUS AND CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES EXPERIENCED. THE CATHETER WAS RETURNED WITH BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, INFLATION LUMEN AND BALLOON, WHICH IS CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND A LEAK OR RUPTURE. THERE WAS ALSO CONTRAST VISIBLE IN THE INFLATION LUMEN AND BALLOON, SUGGESTING THAT THE DEVICE HAD BEEN PREPPED FOR USE. DURING FUNCTIONAL TESTING, THE ANALYSIS WAS ABLE TO CONFIRM A LONGITUDINAL BALLOON RUPTURE OVER THE PROXIMAL BALLOON MARKER. ADDITIONALLY, THERE WAS A LONGITUDINAL SCRATCH EVIDENT NEAR THE RUPTURE LOCATION. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, OR THE TORTUOUS AND CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON INFLATION. FURTHERMORE, THERE WAS NO OTHER DAMAGE NOTED TO THE DEVICE; THEREFORE, BASED ON THE INCIDENT INFO AND RETURNED DEVICE ANALYSIS, THE BALLOON RUPTURE APPEARS TO BE RELATED TO MECHANICAL DAMAGE TO THE BALLOON MATERIAL RESULTING FROM CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    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 DURING THE FIRST PREDILATION OF A MILDLY CALCIFIED LESION, THE BALLOON RUPTURED AT 4 ATM. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 8042241

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK