BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER CORONARY DILATATION CATHETER

    MDR report key: 1920302 · Received December 10, 2010

    Report

    Report Number
    2024168-2010-02667
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 15, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. THE PATIENT ANATOMY WAS MODERATELY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED RUPTURE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, OR PATIENT ANATOMY, SUCH THAT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT 8 ATMOSPHERES WHICH IS BELOW THE RATED BURST PRESSURE (RBP) OF 14 ATMOSPHERES. IT WAS REPORTED A PERFORATION OCCURRED AFTER THE VOYAGER BALLOON RUPTURED AND VENTRICULAR TACHYCARDIA OCCURRED AND THE PATIENT WAS INTUBATED. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE (IFU) FOR THE RX VOYAGER AND OTW VOYAGER LIST PERFORATIONS AND ARRYTHYMIAS (INCLUDING VENTRICULAR TACHYCARDIA) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY DILATATION PROCEDURES. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED. THE UNK GRAFTMASTERS (X3), UNK ABBOTT BMS, AND UNK VOYAGER ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-DILATATION IN THE CALCIFIED CIRCUMFLEX ARTERY THE UNK VOYAGER BALLOON RUPTURED AT 8 ATMOSPHERES AND A PERFORATION OCCURRED. VENTRICULAR TACHYCARDIA OCCURRED AND THE PATIENT WAS INTUBATED. AN UNK GRAFTMASTER COULD NOT BE ADVANCED TO TREAT THE LESION. DURING GRAFTMASTER REMOVAL THE GUIDE CATHETER CAME OUT OF THE LEFT MAIN OSTIUM. THE GRAFTMASTER STENT DISLODGED FROM THE DELIVERY SYSTEM, FLOATING ON THE GUIDE WIRE. ALL DEVICES INCLUDING THE GUIDE WIRE WERE REMOVED; HOWEVER, THE DISLODGED STENT CAME OFF OF THE GUIDE WIRE IN THE PROFUNDA. STENT STILL REMAINS LOOSE IN THE PROFUNDA. AN UNK ABBOTT BARE METAL STENT (BMS) WAS IMPLANTED, BUT WAS UNSUCCESSFUL IN SEALING THE PERFORATION, DELAYING THE PROCEDURE. A SECOND UNK GRAFTMASTER WAS IMPLANTED BUT WAS UNSUCCESSFUL IN SEALING THE PERFORATION. A THIRD UNK GRAFTMASTER WAS IMPLANTED, BUT WAS UNSUCCESSFUL IN SEALING THE PERFORATION. AN UNK 3X5 VOYAGER BALLOON WAS INFLATED BUT WAS UNSUCCESSFUL IN SEALING THE PERFORATION, DELAYING THE PROCEDURE. A 4.0 NC MERLIN WAS INFLATED TO 20 ATMOSPHERES AND SUCCESSFULLY SEALED THE LESION. PERICARDIOCENTESIS WAS PERFORMED WITH 500 CC FLUID RETRIEVED. THE PATIENT'S CONDITION IMPROVED AND HE WAS DISCHARGED ON (B)(6) 2010. THE DISLODGED GRAFTMASTER STENT REMAINS FLOATING IN THE LOWER EXTREMITY. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 3.5X23 VISION STENT DELIVERY SYSTEM