BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL/VAXCEL

    MDR report key: 2309901 · Received October 20, 2011

    Report

    Report Number
    1317056-2011-00092
    Event Type
    Injury
    Date Received
    October 20, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 21, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE AUGUST 2011 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF VAXCEL PASV PORTS AND THE FAILURE MODE OF "CATHETER FRACTURED." NO ADVERSE TRENDS WERE IDENTIFIED. ONE PORT ASSEMBLY WITH ATTACHED CATHETER WAS RETURNED FOR EVALUATION. VISUAL INSPECTION SHOWED THAT THE CATHETER TUBING CONTAINED A LONGITUDINAL CRACK AT THE 10CM MARK. A FUNCTIONAL CHECK OF THE PORT ASSEMBLY, IN WHICH AIR WAS INFUSED THROUGH A 22G. NON-CORING NEEDLE INTO THE PORT, CONFIRMED LEAKAGE THROUGH THE CRACK IN THE CATHETER. DIMENSIONAL MEASUREMENTS OF THE CATHETER ID AND OD FOUND IT TO BE WITHIN PRODUCT SPECIFICATION. A SUPPLIER CORRECTIVE ACTION REQUEST AS SENT TO NAVILYST MEDICAL'S CATHETER TUBING SUPPLIER, HTP-MEDS, LLC. THEIR REVIEW OF THE TUBING DHR INDICATED THAT IT CONTAINED NO MANUFACTURING DEFECTS AND MET SPECIFICATION PRIOR TO SHIPMENT. THE COMPLAINT IS CONFIRMED FOR A FRACTURE IN THE CATHETER TUBING. THE APPEARANCE OF THE CATHETER (CRACKED, FLATTENED IN THE AREA OF THE CRACK AND EVIDENCE OF ABRASION TO THE CATHETER SURFACE) INDICATE THAT "PINCH-OFF SYNDROME" IS THE MOST LIKELY CAUSE OF THE CATHETER FRACTURE. "PINCH-OFF SYNDROME" IS THE PINCHING, WEAR, OR KINKING OF THE CATHETER BETWEEN THE FIRST RIB AND CLAVICLE WITHIN THE TUNNELED REGION. THE DIRECTIONS FOR USE SUPPLIED WITH THE DEVICE INSTRUCTS THE PHYSICIAN/CLINICIAN ON HOW TO PROPERLY IMPLANT THE CATHETER/PORT, AND CAUTIONS AGAINST CERTAIN HANDLING TECHNIQUES TO AVOID "PINCH-OFF SYNDROME." THE END USER ATTACHES THE CATHETER TUBING TO THE PORT. NAVILYST MEDICAL INCOMING INSPECTION OF THE CHEST PORT CATHETERS INCLUDES DIMENSIONAL INSPECTIONS, STATIC BURST TESTING, AND TENSILE TESTING. (B)(4).

    Description of Event or Problem · 1

    NAVILYST MEDICAL WAS NOTIFIED OF THIS EVENT BY THE PATIENT: A VALVED CHEST PORT WAS PLACED ON (B)(6) 2010. ON (B)(6) 2011, DURING AN INFUSION OF ZOMETA, THE "PATIENT BECAME SYMPTOMATIC WITH SHOOTING PAINS DOWN LEFT ARM." THE INFUSION WAS STOPPED AND THE PATIENT WAS SENT TO SHORE MEMORIAL IR DEPT. FOR A PORTOCATHOGRAM. CONTRAST SHOWED THE PORT SITE TO HAVE "EXTRAVASATION AS IT PASSES UNDER CLAVICLE. MEDICATION WAS FREE-FLOATING AND THE CATHETER WAS FRAYED/CRACKED." THE PATIENT'S ONCOLOGIST WAS NOTIFIED, AND THE PORT WAS REMOVED AT ACCESS SURGERY CENTER. THE PORT HAD PREVIOUSLY BEEN FLUSHED AT LEAST ONCE A MONTH SINCE IT WAS IMPLANTED. THE PATIENT INDICATED THAT SINCE HER FOLLOW-UP SHE HAS HAD "SWELLING IN LEFT BREAST AND TENDERNESS IN ARM AND TINGLING IN PINKY FINGER ON LEFT HAND." THE USED DEVICE HAS BEEN RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL/VAXCEL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT NAVILYST MEDICAL NA 1361868

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention