BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    MDR report key: 1000049 · Received February 15, 2008

    Report

    Report Number
    3004742046-2008-00035
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND A CIRCUMFERENTIAL SEPARATION CLOSE TO THE PROXIMAL SHOULDER. THE DISTAL TIP (INCLUDING THE DISTAL PORTION OF THE BALLOON) AND 6MM OF THE DISTAL PORTION OF THE INNER MEMBER WERE SEPARATED AND NOT RETURNED, WHICH MAY HAVE PROVIDED ADD'L INFO FOR THE INVESTIGATION. THE PROXIMAL PORTION OF THE RETURNED SHAFT WAS TORN (WITH JAGGED EDGES) AND A KINK WAS OBSERVED INDICATING A TENSILE OVERLOAD. SCANNING ELECTRON MICROSCOPY (SEM) FOUND THE BALLOON SEPARATION WAS ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. SEM ALSO ATTRIBUTED THE INNER MEMBER FAILURE TO TENSILE OVERLOAD. THERE WAS NO MENTION OF ANY RESISTANCE FELT DURING THE PROCEDURE WHICH WOULD BE EXPECTED WITH THE MECHANICAL DAMAGE NOTED TO THE BALLOON OUTSIDE DIAMETER, SEPARATED BALLOON, SEPARATED GUIDE WIRE LUMEN, AND SEPARATED PROXIMAL SHAFT. A REVIEW OF THE LOT HISTORY RECORD INDICATED THAT SAMPLE TEST RUPTURE VALUES AND TENSILE VALUES FOR THE SHAFT WERE WELL ABOVE PRODUCT SPECIFICATION. A ROOT CAUSE FOR THE BALLOON RUPTURE, BALLOON SEPARATION, SEPARATED GUIDE WIRE LUMEN, AND THE KINK AND SEPARATED PROXIMAL SHAFT COULD NOT BE DETERMINED. THIS TYPE OF DAMAGE APPEARS TO BE PROCEDURAL RELATED. ALL RX VIATRAC PLUS CATHETERS ARE 100% INSPECTED FOR INFLATION TO RATED BURST PRESSURE AND 100% INSPECTED VISUALLY FOR SHAFT DAMAGE. IN ADDITION, A SAMPLING FROM EACH LOT IS DESTRUCTIVELY TESTED TO BALLOON RUPTURE PRESSURE AND SHAFT TENSILE TESTING IS ALSO PERFORMED. NO MFG ISSUES WERE IDENTIFIED. REVIEW OF THE LOT HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SHAFT BREAKAGE, RUPTURED AND DETACHED BALLOON. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT THE VIATRAC WAS USED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY. THE BALLOON REPORTEDLY RUPTURED CIRCUMFERENTIALLY AT AN UNSPECIFIED PRESSURE. DURING WITHDRAWAL OF THE VIATRAC FROM THE PT, A PORTION OF THE BALLOON SEPARATED FROM THE CATHETER AND A SHAFT BREAKAGE OCCURRED. A GOOSENECK SYSTEM WAS USED TO RETRIEVE THE REMAINING BALLOON PORTION. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7082351

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention GOOSENECK SNARE