BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1812805 · Received July 10, 2010

    Report

    Report Number
    2024168-2010-01434
    Event Type
    Injury
    Date Received
    July 10, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 23, 2010
    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
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE XIENCE V 2.5 X 28 (PART 1009539-28, LOT UNK) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND THE BALLOON CATHETER WITH BLOOD ON THE HUB, SHAFT, IN THE HUB, INFLATION LUMEN, BALLOON, AND IN THE GUIDE WIRE. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS RETURNED LOOSELY FOLDED. THE HYPOTUBE HAD SEPARATED 54.8 CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVALED AS IF KINKED PRIOR TO SEPARATING. THE HYPOTUBE JACKET WAS STRETCHED AND SEPARATED AT THE SAME LOCATION. THE DISTAL SEPARATED PORTION OF THE BALLOON CATHETER WAS RETURNED INSIDE A NON-ABBOTT GUIDING CATHETER. THERE WERE KINKS IN THE HYPOTUBE 22.8 CM AND 50.7 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS A BEND IN THE HYPOTUBE 26.5 CM DISTAL TO THE SEPARATION. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE NON-ABBOTT GUIDING CATHETER WAS RETURNED WITH BLOOD ON AND IN THE GUIDING CATHETER THROUGHOUT THE ENTIRE LENGTH. THE SHAFT OF THE GUIDING CATHETER WAS FLATTENED 85.5 CM DISTAL TO THE BASE OF THE LUER FOR A LENGTH OF 1 CM. THERE WAS NO OTHER DAMAGE NOTED TO THE NON-ABBOTT GUIDING CATHETER. A NEW INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE BALLOON. THE BALLOON WAS PRESSURIZED TO 18 ATMOSPHERE AND THERE WERE NO LEAKS NOR RUPTURE NOTED. THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE STENT DELIVERY SYSTEM (SDS) MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. IN THIS CASE, IT IS LIKELY THAT AS THE VOYAGER NC WAS ADVANCED IN THE HEAVILY CALCIFIED LESION, THE SHAFT KINKED. FURTHER MANIPULATION IN THE LESION AS THE BALLOON WAS PRESSURIZED COULD HAVE CONTRIBUTED TO THE SHAFT PARTIALLY SEPARATING, RESULTING IN A LOSS OF PRESSURE TO THE BALLOON, WHICH WOULD HAVE BEEN PERCEIVED BY THE ACCOUNT AS A BALLOON RUPTURE. THE CATHETER WOULD HAVE THEN ENCOUNTERED RESISTANCE DURING RETRACTION DUE TO THE SHAFT KINKS AND SEPARATION, REQUIRING THE USE OF A SNARE DEVICE TO RETRIEVE THE SEPARATED PORTION. IN THIS CASE, THE REPORTED SHAFT SEPARATION AND DIFFICULTY REMOVING THE CATHETER APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCT MFG RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MFG CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MFG PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: SHAFT SEPARATION. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: MEDICAL INTERVENTION TO REMOVE SEPARATED SHAFT. TIME OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT IN-STENT RESTENOSIS (ISR) OF A XIENCE V STENT THAT HAD BEEN PREVIOUSLY DEPLOYED (DATE OF STENT DEPLOYMENT IS UNK). THE ISR WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA), WHICH WAS HEAVILY CALCIFIED. IVUS WAS PERFORMED AND THE STENT WAS REPORTEDLY UNDER DEPLOYED (RECOILED). A 2.0 VOYAGER WAS USED FOR PRE-DILATION WITHOUT AN ISSUE. A 3.5 X 20 NC VOYAGER WAS USED WITH AN AL1 6FR GUIDING CATHETER AND A NON-ABBOTT GUIDE WIRE (SHORT LENGTH). THE NC VOYAGER WAS ADVANCED TO THE ISR AND UPON INFLATION THE BALLOON RUPTURED AT 10 ATMOSPHERE. DURING REMOVAL OF THE NC VOYAGER THERE WAS RESISTANCE AND THE SHAFT OF THE DEVICE SEPARATED. A SNARE DEVICE WAS USED TO PULL THE SEPARATED PORTION OF THE BALLOON CATHETER INTO THE GUIDING CATHETER AND THE TWO DEVICES WERE SUCCESSFULLY REMOVED AS A SINGLE UNIT. THE VESSEL WAS REWIRED AND AN ADDITIONAL BALLOON CATHETER WAS USED TO TREAT THE ISR WITH GOOD RESULTS. NO ADDITIONAL EVENT OR PT INFORMATION IS AVAILABLE. USER FACILITY MEDWATCH RECEIVED STATES, "BALLOON RUPTURE RESULTING IN BALLOON WIRE BREAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 0012761

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention XIENCE V 2.5 X 28 (PART 1009539-28, LOT UNK)| 2.0 VOYAGER DILATATION CATHETER| 6 FR GUIDING CATHER