BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT

    MDR report key: 4875027 · Received June 25, 2015

    Report

    Report Number
    1820334-2015-00387
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 8, 2015
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DWF
    PMA / PMN Number
    K931586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY DEVICE HISTORY RECORD AND THE INSTRUCTIONS FOR USE (I FU) WAS CONDUCTED FOR THE PURPOSE OF THIS INVESTIGATION. NO DEVICE WAS RETURNED TO ASSIST WITH THE INVESTIGATION. IN ADDITION, NO PHOTOS OF THE DEVICE WERE PROVIDED, SO A VISUAL INSPECTION TO DETERMINE THE NATURE OF THE CATHETER FRACTURE COULD NOT BE PERFORMED. ACCORDING TO INFORMATION PROVIDED IN THE COMPLAINT, A VITAL PORT CATHETER FRACTURED AFTER 5 YEARS OF IMPLANTATION IN THE UPPER ARM. NO SPECIFIC INFORMATION ABOUT THE IMPLANTATION LOCATION WAS PROVIDED, THOUGH THERE IS NO INDICATION THIS LOCATION DOES NOT FOLLOW THAT RECOMMENDED IN THE IFU. MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED, AND NO EVIDENCE OF MANUFACTURING NONCONFORMITY WAS FOUND. IN ADDITION, NO OTHER COMPLAINTS HAVE BEEN FILED FOR THIS DEVICE LOT. BASED ON THIS INFORMATION, THE ROOT CAUSE AS TO WHY THE FRACTURE OCCURRED IS UNKNOWN. NO CONCLUSION CAN BE DRAWN. INSUFFICIENT RISK DUE IN PART TO HIGH DETECTION ACTIVITIES, LOW OCCURRENCE AND LOW SEVENTY NO FURTHER RISK REDUCTION IS REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A VITAL PORT WAS IMPLANTED ON A (B)(6) WOMAN ON (B)(6) 2010. THE LAST RADIOLOGY CHECK OF UNOBSTRUCTED PORT IN USE BY DEPARTMENT OCCURRED ON (B)(6) 2011. PREPARATIONS FOR PORT EXPLANTATION OCCURRED ON (B)(6) 2015. BASED ON THE FINDINGS, THE CATHETER BROKE IN THE RIGHT UPPER ARM, DISLOCATING THE SILICON CATHETER IN THE PULMONARY, CAUSING CATHETER EMBOLUS. THE PORT CHAMBER FROM UPPER ARM WAS EXPLANTED ON THE SAME DAY. MINIMAL INVASIVE REMOVAL OF THE CATHETER WAS PERFORMED. THE PATIENT WAS DISMISSED ON (B)(6) 2015 AND WAS DOING WELL AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410911 VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT DWF COOK VASCULAR INC. NA N86986

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention