BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1831800 · Received September 8, 2010

    Report

    Report Number
    2024168-2010-01873
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 17, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CRYSTALLIZED CONTRAST IN THE INFLATION LUMEN AND BALLOON. THIS IS CONSISTENT WITH PREPARATION AND THE CATHETER BEING ADVANCED INTO THE PATIENT ANATOMY. THE BALLOON WAS LOOSELY FOLDED. THE HYPOTUBE AND JACKET MATERIAL WERE SEPARATED 31.6 CM DISTAL TO THE STRAIN RELIEF TUBING, CONFIRMING THE REPORTED SEPARATION. THE FRACTURE FACES WERE OVAL AS IF KINKED PRIOR TO SEPARATION. THE MATERIAL AT THE SEPARATION WAS JAGGED AND STRETCHED. 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 REMOVE MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. THERE WERE MULTIPLE KINKS AND BENDS NOTED TO THE CATHETER. IN THIS CASE, IT IS LIKELY THAT THE SHAFT KINKS ARE RELATED TO USE OF THE PRODUCT, AS THE KINKS WERE NOT NOTED DURING INSPECTION PRIOR TO USE. THE PATIENT ANATOMICAL INFORMATION WAS NOT REPORTED WHICH MAY HAVE AIDED IN THE EVALUATION AND DETERMINATION OF CAUSE. IT IS POSSIBLE THE SHAFT KINKED DURING ADVANCEMENT OF THE CATHETER IN THE LESION. FURTHER MANIPULATION OF THE CATHETER WOULD HAVE CONTRIBUTED TO THE SHAFT SEPARATING. SEVERAL ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION AS TO THE CASE CIRCUMSTANCES; HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED HYPOTUBE SEPARATION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEVICE ISSUE: SHAFT SEPARATION. TIME OF DEVICE ISSUE: UNSPECIFIED TIME OF THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE SHAFT OF THE VOYAGER NC BROKE DURING AN UNSPECIFIED TIME OF THE PROCEDURE IN AN UNSPECIFIED TARGET VESSEL. ANOTHER UNSPECIFIED BALLOON WAS USED FOR POST DILATATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 0031061

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: FIELDER, GRANSLAM.