BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 990406 · Received February 1, 2008

    Report

    Report Number
    2024168-2008-00069
    Event Type
    Injury
    Date Received
    February 1, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 3, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITH BLOOD IN THE GUIDE WIRE LUMEN. THERE WAS BLOOD AND CONTRAST IN THE INFLATION LUMEN AND IN THE BALLOON. THE BALLOON WAS PARTIALLY FILLED WITH BLOOD AND CONTRAST. THERE WAS NO DAMAGE NOTED TO THE CATHETER. AN INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE THE CATHETER WHEN THE BALLOON WOULD NOT PRESSURIZE DUE TO THE CHICK BLOOD AND CONTRAST AND TO PRESSURIZE THE BALLOON. AFTER BEING LEFT PRESSURIZED FOR THREE DAYS, THE BALLOON PRESSURIZED TO REVEAL A PINHOLE IN THE BALLOON. THE PINHOLE WAS LOCATED 8MM DISTAL TO THE PROXIMAL TAPER OF THE BALLOON. THERE WERE MULTIPLE SCRATCHES ON THE BALLOON FOR A LENGTH OF 2 MM PROXIMAL TO THE PINHOLE AND ALSO SCRATCHES ON THE OPPOSITE SIDE OF THE PINHOLE IN THE BALLOON. DUE TO THE PINHOLE IN THE BALLOON, THE BALLOON COULD NOT BE FULLY PRESSURIZED TO DETERMINE IF THERE WAS A WAIST IN THE BALLOON. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. IT WAS REPORTED THAT DURING INFLATION TO 18 ATM, THE BALLOON OF THE RX VOYAGER APPEARED TO HAVE A WAIST, AND THEN IT RUPTURED. THE RUPTURE RESULTED IN A DISSECTION OF THE VESSEL, WHICH WAS TREATED WITH FIVE MINI VISION STENTS. ANALYSIS OF THE RETURNED RX VOYAGER CONFIRMED THE PINHOLE RUPTURE AND ALSO NOTED SCRATCHES ON THE BALLOON JUST PROXIMAL TO THE PINHOLE AS WELL AS ON THE OPPOSITE SIDE OF THE BALLOON. SCRATCHES NEAR THE RUPTURE SITE SUGGEST THAT THE BALLOON WAS MECHANICALLY DAMAGED PRIOR TO RUPTURING, PERHAPS AS A RESULT OF MANUFACTURING, MISHANDLING, OR INTERACTIONS WITH PATIENT ANATOMY OR OTHER DEVICES. THE PATIENT ANATOMY WAS NOT DESCRIBED IN THIS INCIDENT, WHICH WOULD HAVE AIDED THE INVESTIGATION. REPORTEDLY, THE BALLOON INFLATED WITH A WAIST. THIS CAN HAPPEN DUE TO MANUFACTURING OF THE CATHETER, OR AS A RESULT OF SIGNIFICANT STENOSIS AT THE CENTER OF THE BALLOON AS IT IS EXPANDED. THE WAIST COULD NOT BE CONFIRMED AS THE RUPTURE BALLOON COULD NOT BE INFLATED. IF THERE WAS SIGNIFICANT STENOSIS OR CALCIFICATION AT THAT LOCATION, IT IS POSSIBLE THAT IT MAY HAVE CONTRIBUTED TO DAMAGING THE BALLOON MATERIALS SUCH THAT IT RUPTURED UPON INFLATION. THIS SCENARIO COULD ALSO ACCOUNT FOR THE DAMAGE ON THE OPPOSITE SIDE OF THE BALLOON. HOWEVER, SINCE THE PATIENT ANATOMY CANNOT BE CONFIRMED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE MECHANICAL DAMAGE THAT CONTRIBUTED TO THE BALLOON RUPTURE. THE RX VOYAGER IFUS STATES: "BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). THE RBP IS BASED ON RESULTS OF IN VITRO TESTING. AT LEAST 99.9% OF THE BALLOONS (WITH A 95% CONFIDENCE) WILL NOT BURST AT OR BELOW THEIR RBP." IT IS POSSIBLE THAT THE HIGH PRESSURE INFLATION MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE. AS A RESULT OF THE BALLOON RUPTURE, THE VESSEL WAS DISSECTED. VESSEL DISSECTION IS A KNOWN RESULT OF PTCI PROCEDURES, AND IS LISTED IN BOTH THE RX VOYAGER RISK ASSESSMENT MATRIX AND THE IFU. IN THIS CASE, THE DISSECTION WAS SUCCESSFULLY TREATED WITH THE PLACEMENT OF SEVERAL MINI VISION STENT IMPLANTS. A REVIEW OF THE FINISHED LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: BALLOON RUPTURE, SUBSEQUENT DISSECTION. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT PREDILATATION WAS DONE WITH THE VOYAGER, WHICH HAD A WAIST DURING INFLATION. IT WAS INFLATED TO 18 ATM, WHICH IS ABOVE RATED BURST PRESSURE (RBP), AND THE BALLOON RUPTURED. THE VESSEL WAS DISSECTED AND WAS TREATED WITH THE PLACEMENT OF FIVE ADDITIONAL MINI VISION STENTS. 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 74LOX LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7090432

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention