BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1983649 · Received February 10, 2011

    Report

    Report Number
    2024168-2011-00793
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST VISIBLE IN THE GUIDE WIRE LUMEN AND LOOSELY FOLDED BALLOON, WHICH IS CONSISTENT WITH PREPARATION AND LEAK WHILE IN THE PATIENT ANATOMY. THE DISTAL SHAFT WAS SEPARATED AT THE GUIDE WIRE EXIT NOTCH. THE GUIDE WIRE EXIT NOTCH WAS STRETCHED AND TWISTED FOR A LENGTH OF 1.7 CM. THE SUPPORT MANDREL WAS STILL INTACT. THERE WERE MULTIPLE KINKS THROUGHOUT THE FULL LENGTH OF THE HYPOTUBE, WHICH MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A NEW INDEFLATOR WAS ATTACHED TO THE DISTAL SHAFT USING A LUER AND THE SHAFT PRESSURIZED AND THE BALLOON INFLATED. THERE WAS NO BALLOON RUPTURE AS REPORTED. IT IS LIKELY THAT THE SHAFT SEPARATION WAS WHAT WAS PERCEIVED BY THE ACCOUNT AS A BALLOON RUPTURE. FACTORS THAT CAN CONTRIBUTE TO SHAFT SEPARATIONS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING DURING PREPARATION, PRODUCT PLACEMENT TECHNIQUE, FRACTURE/KINKED SHAFT, WEAK SEALS OR INTERACTION WITH THE GUIDE WIRE. IN THIS CASE, IT IS POSSIBLE THE CATHETER EXPERIENCED RESISTANCE WITH THE GUIDE WIRE, AS THE TEARING OF THE GUIDE WIRE EXIT NOTCH APPEARS TO HAVE RESULTED FROM AN INTERACTION WITH THE GUIDE WIRE. THIS TYPE OF MECHANICAL DAMAGE CAN OCCUR IF AN ATTEMPT IS MADE TO PULL THE DILATATION CATHETER IN AN OPPOSITE DIRECTION AS THE GUIDE WIRE. THE USED GUIDE WIRE WAS NOT RETURNED, WHICH MAY HAVE AIDED IN THE INVESTIGATION. AS RESISTANCE WAS ENCOUNTERED, IF FORCE WAS APPLIED, IT WOULD CONTRIBUTE TO THE STRETCHING, TWISTING, AND ULTIMATELY THE SEPARATION OF THE SHAFT; HOWEVER, AS THERE WAS NO RESISTANCE NOTED, THIS COULD NOT BE CONFIRMED. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE SHAFT SEPARATION COULD NOT BE DETERMINED. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE, THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE AND THE SHAFT SEPARATED. THE SEPARATED SHAFT WAS RETRIEVED USING A SNARE DEVICE. ANOTHER VOYAGER OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT EFFECT. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0112463

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention