BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1712206 · Received May 27, 2010

    Report

    Report Number
    2024168-2010-01050
    Event Type
    Malfunction
    Date Received
    May 27, 2010
    Date of Event
    April 21, 2010
    Report Date
    April 21, 2010
    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
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VOYAGER NC (PART# 1011753-15, LOT# 9091861) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVALUATION SUMMARY: THE BALLOON CATHETER WAS RETURNED WITH BLOOD ON THE SHAFT AND BALLOON. THERE WAS CRYSTALLIZED CONTRAST IN THE INFLATION LUMEN AND IN THE BALLOON. THE BALLOON WAS RETURNED LOOSELY FOLDED. THERE WAS A LONGITUDINAL RUPTURE IN THE BALLOON OVER THE DISTAL BALLOON MARKER. THE RUPTURE EXTENDED DISTALLY FOR A LENGTH OF 1 MM AND PROXIMALLY FOR A LENGTH OF 2 MM. THERE WAS A RADIAL SCRATCH OVER THE DISTAL BALLOON MARKER. THERE WAS AN INDENTATION AND SLIGHT RING AROUND THE BALLOON PROXIMAL TO THE DISTAL BALLOON MARKER. THERE WERE MULTIPLE BENDS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. A NEW INDEFLATOR FILLED WITH WATER WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON WHEN FLUID LEAKED OUT THE LONGITUDINAL RUPTURE IN THE BALLOON. BALLOON RUPTURES CAN OCCUR AS A RESULT OF A MANUFACTURING DEFICIENCY (SUCH AS DAMAGE TO THE BALLOON DURING THE PROCESSING OF THE BALLOON MATERIAL), INSUFFICIENT PREPARATION PRIOR TO USE OR FROM USE OF THE DEVICE. DURING USE THERE CAN BE AN INTERACTION WITH ANATOMY, A PREVIOUSLY IMPLANTED STENT AND/OR ACCESSORY DEVICES, WHICH CAN DAMAGE OR WEAKEN THE BALLOON MATERIAL AND LEAD TO RUPTURE DURING INFLATION. IN THIS CASE, THE BALLOON WAS INFLATED TO 20 ATM (ATMOSPHERE), WHICH IS ABOVE RATED BURST PRESSURE (RBP) OF 18 ATM. IT SHOULD BE NOTED THAT THE VOYAGER NC INSTRUCTION FOR USE (IFU) STATES: THE BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). THE RBP IS BASED ON THE RESULTS OF IN VITRO TESTING. AT LEAST 99.9% OF THE BALLOONS (WITH A 95% CONFIDENCE) WILL NOT BURST AT OR BELOW THEIR RBP. USE OF A PRESSURE-MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER PRESSURIZATION. ADDITIONALLY, THE ANATOMICAL CONDITIONS REPORTED MILD CALCIFICATION, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED BALLOON RUPTURE IN ADDITION TO INFLATING ABOVE RBP. THE NOTED BALLOON SCRATCH AND INDENTATION COULD HAVE RESULTED FROM THE REPORTED CALCIFICATION; HOWEVER, IT IS UNK IF THEY CONTRIBUTED TO THE BALLOON RUPTURE. THEREFORE, THE BALLOON RUPTURE RESULTED IN THE INFLATION ISSUE DURING THE PROCEDURE. THE ANALYSIS NOTED MULTIPLE BENDS THROUGH THE ENTIRE LENGTH OF THE HYPOTUBE. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE NOTED DAMAGE WAS NOT REPORTED AND LIKELY RESULTED FROM HANDLING OF THE PRODUCT POST-PROCEDURE DURING PACKING FOR SHIPMENT BACK TO ABBOTT VASCULAR. THE NOTED DAMAGE DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE INFLATION ISSUE CROSS. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS. THE REPORTED INFLATION ISSUE (BALLOON RUPTURE) APPEARS TO BE RELATED TO THE CIRCUMSTANCE OF THE PROCEDURE AND THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BALLOON PRESSURE AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: BALLOON RUPTURE. TIME OF DEVICE ISSUE: DURING PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE FIRST INFLATION OF THE 2.75 X 08 VOYAGER NC BALLOON WAS TO 20 ATM. A BALLOON RUPTURE OCCURRED WITH THE CATHETER DURING THE SECOND INFLATION. THE DEVICE WAS REMOVED AND A SECOND 2.75 X 15 VOYAGER NC BALLOON CATHETER WAS USED WITH THE SAME RESULTS, HOWEVER, THERE IS NO INFO REGARDING THE FIRST INFLATION ATM FOR THIS DEVICE. A THIRD 2.75 X 12 VOYAGER NC BALLOON CATHETER WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED. DURING RETURN DEVICE ANALYSIS, BOTH VOYAGER NC BALLOONS WERE OBSERVED TO BE RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9111261

    Patients

    Seq Age Sex Outcome Treatment
    1 VOYAGER NC (PART# 1011753-15, LOT# 9091861)