BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1050325 · Received May 22, 2008

    Report

    Report Number
    2024168-2008-00418
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 22, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE STENT DISLODGEMENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITHOUT ANY BLOOD VISIBLE. THERE WAS FLUID VISIBLE IN THE INFLATION LUMEN. THE BALLOON AND INNER MEMBER WERE SEPARATED AT THE PROXIMAL SEAL AND WERE NOT RETURNED. THERE WAS 1.7 CM OF INNER MEMBER STICKING OUT OF THE INFLATION LUMEN. THE SEPARATED EDGE OF THE INNER MEMBER WAS STRETCHED AND JAGGED. THE PROXIMAL SHAFT OF THE CATHETER WAS WAVY DUE TO THE WAY IT WAS RETURNED WITH THE OTHER DEVICES. THE GUIDING CATHETER AND COPILOT USED IN THE PROCEDURE WERE RETURNED. THE GUIDING CATHETER WAS FLUSHED NUMEROUS TIMES TO VERIFY IF THE BALLOON AND INNER MEMBER WERE IN THE SHAFT. NOTHING WAS FOUND BY FLUSHING THE GUIDING CATHETER. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED. PRODUCT PERFORMANCE ENGINEERING HAS REVIEWED CASE DESCRIPTION AND ANALYSIS OF THE RETURNED DEVICE; DAMAGE WAS NOTED. THE ANALYSIS WAS ABLE TO CONFIRM THE REPORTED DIFFICULTY, AS A SEPARATION OF THE BALLOON AND INNER MEMBER WERE CONFIRMED AT THE PROXIMAL SEAL AREA. FACTORS THAT MAY CONTRIBUTE TO THE SEPARATION OF THE BALLOON INCLUDE, BUT NOT LIMITED TO, MANUFACTURING, MATERIALS, WEAKENED SEALS, TENSILE OVERLOAD, KINKS, PATIENT ANATOMY/CALCIFICATION, ASSOCIATIVE DEVICE INTERACTION. THE BALLOON HAD SEPARATED DURING THE 2ND DEFLATION ATTEMPT AFTER IT WAS SUCCESSFULLY INFLATED AND DEFLATED. THE SEPARATED FRACTURE FACES OF THE INNER MEMBER WERE JAGGED AND STRETCHED, WHICH SUGGESTS THE DEVICE WAS SUBJECTED TO TENSILE OVERLOAD BEYOND ITS DESIGN LIMITS. HOWEVER, THERE WAS NO MENTION OF MANEUVERING THE BALLOON CATHETER UNDER RESISTANCE. A REVIEW OF THE CINE IMAGES SUGGESTS THE BALLOON MAY HAVE REMAINED IN THE PT ANATOMY OR ON THE DISCARDED USED GUIDE WIRE, AS THERE WAS NO BALLOON MATERIAL FOUND WHEN THE RETURNED GUIDING CATHETER WAS FLUSHED. THE DISTAL PORTION OF THE BALLOON WAS NOT RETURNED, WHICH WOULD HAVE AIDED IN THE INVESTIGATION. BASED ON A REVIEW OF THE CASE DESCRIPTION AND RETURNED DEVICE, A CONCLUSIVE ROOT CAUSE OF THE REPORTED SHAFT/BALLOON SEPARATION COULD NOT BE DETERMINED. THE IFU STATES "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 95% CONFIDENCE) WILL NOT BURST AT OR BELOW THEIR RBP." THE RBP OF THE VOYAGER BALLOON CATHETER DEVICE IS 14 ATM. OVER INFLATION OF THE BALLOON MAY CONTRIBUTE TO POTENTIAL ADVERSE EFFECTS DURING THE PROCEDURE; ALTHOUGH, THERE WAS NO ISSUE RELATED TO OVER INFLATION. THE MANUFACTURING LOT HISTORY RECORD WAS REVIEWED AND THERE ARE NO NONCONFORMANCES ASSOCIATED WITH THIS PRODUCT PART/LOT NUMBER COMBINATION. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY. REPORTING RATIONALE: FOREIGN MATERIAL LEFT IN THE PATIENT'S ANATOMY. DEVICE ISSUE: SHAFT/BALLOON SEPARATION. IT WAS REPORTED THAT THE VOYAGER BALLOON CATHETER WAS BEING USED TO POST DILATE ANOTHER CO'S DRUG ELUTING STENT THAT WAS BEING USED TO COVER A DISSECTION IN THE LEFT MAIN. DURING THE ATTEMPT TO DEFLATE THE BALLOON, IT COULD NOT BE VISUALIZED ON THE FLUOROSCOPY. ALL THE DEVICES WERE REMOVED AS A SINGLE UNIT. FLUOROSCOPY OF THE PT'S ANATOMY WAS DONE AND THE BALLOON WAS NOT SEEN IN THE ANATOMY. THE GUIDING CATHETER WAS FLUSHED, BUT THE BALLOON WAS NOT FOUND. REPORTEDLY, THE PT IS FINE. NO ADDITIONAL EVENT OR PT INFORMATION IS AVAILABLE. THIS IS BEING FILED BASED ON THE CINE REVIEWER'S REPORT WHICH REVEALED THAT THERE IS A POSSIBILITY THAT THE MISSING PORTION OF THE BALLOON CATHETER REMAINS IN THE PATIENT'S CORONARY. THE REPORT STATED. "THERE IS CONTRAST SEEN IN THE DISTAL LAD THAT APPEARS TO BE A FOCAL FILLING DEFECT. THIS REVIEWER CANNOT CONFIRM THAT THE FILLING DEFECT IS THE MISSING BALLOON; HOWEVER, IT DOES APPEAR TO BE A POSSIBILITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YOYAGER RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8022131

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Disability INFLATION: 20/20 INDEFLATOR| STENT: CYPHER