BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

    MDR report key: 6176535 · Received December 15, 2016

    Report

    Report Number
    2522007-2016-00015
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    October 4, 2016
    Report Date
    November 22, 2016
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DWF
    UDI-DI
    00827002264724
    PMA / PMN Number
    K931586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME) VITAL-PORT DETACHED SILICONE CATHETER WITH INTRODUCER SET AND OBTURATOR TITANIUM INFUSION PORT. COMMON DEVICE NAME) DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS. PMA#) K931586. INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE; SPECIFIC ITEMS ARE ADDRESSED SUCH AS: WARNINGS: "INTRODUCTION OF THE CATHETER INTO THE SUBCLAVIAN VEIN USING STANDARD PERCUTANEOUS TECHNIQUES MAY SUBJECT THE CATHETER TO PERIODIC COMPRESSION FORCES WITHIN THE NARROW COSTOCLAVICULAR SPACE BETWEEN THE CLAVICLE AND THE FIRST RIB. REPORTED COMPLICATIONS FROM REPEATED SUBCLAVIAN COMPRESSION INCLUDE CATHETER PINCH OFF SYNDROME, CATHETER FRACTURE, AND CATHETER SHEAR FOLLOWED BY EMBOLIZATION OF THE DISTAL PORTION." BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED: "PATIENT PRESENTED WITH PORTA-CATH DEVICE IN RT. ARM THAT WAS NON-FUNCTIONAL. PHLEBOTOMIST UNABLE TO ASPIRATE OR INSTILL. X-RAYS REVEALED FRACTURE LINE ABOUT 1 CM FROM RESERVOIR. MAJORITY OF LINE LOCATED IN RT. ATRIUM, RT. VENTRICLE AND PULMONARY ARTERY. THIS COMPLICATION HAS A 60% RISK OF MORTALITY." NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825416 DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF COOK VASCULAR INC N/A 00827002264724

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention