BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKDRAW VENOUS CANNULA

    MDR report key: 1911131 · Received November 30, 2010

    Report

    Report Number
    3008500478-2010-00021
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 3, 2010
    Report Date
    January 31, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CANNULA, SEPARATION. DEVICE WAS TAKEN TO RISK MANAGEMENT AT THE HOSPITAL AND WAS INSPECTED BY THEIR INTERNAL CLINICAL ENGINEER THEN RETURNED TO MANUFACTURER (EDWARDS LIFESCIENCES) FOR FURTHER ANALYSIS, PER OUR REQUEST. EVALUATION RESULTS FROM EDWARDS LIFESCIENCES ARE CURRENTLY OUTSTANDING AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: IN RESPONSE TO THIS REPORTED EVENT, EDWARDS LIFESCIENCES HAS PERFORMED THE FOLLOWING INVESTIGATION: THE QD25 DEVICE WAS EVALUATED BY THE EDWARDS PRODUCT EVALUATION LAB IN IRVINE WITH THE FOLLOWING REPORT: REPORTED DEFECT OF "DISTAL TIP OF THE CATHETER BROKE OFF" WAS CONFIRMED. REC'D (1) QD25 CANNULA. BLOOD WAS VISIBLE THROUGHOUT THE UNIT. TIP OF THE CANNULA WAS COMPLETELY SEPARATED AT THE DRAINAGE HOLE, APPROXIMATELY 6CM FROM THE TIP. CANNULA BODY WAS ALSO PARTIALLY SEPARATED AT DRAINAGE HOLES AT 8 AND 10CM PROXIMAL FROM THE TIP. THE END OF WIRE WAS ALSO EXPOSED AT 8CM PROXIMAL FROM THE TIP. UNIT IS SENT TO (B)(6) FOR FURTHER EVALUATION. THIS QD WAS ALSO EVALUATED BY ENGINEERING AT EDWARDS (B)(4) AND THE REPORTED DEFECT WAS CONFIRMED. THE TIP OF THE CANNULA WAS SEPARATED AT THE SECOND SET OF DRAINAGE HOLES. CANNULA BODY WAS ALSO PARTIALLY SEPARATED AT DRAINAGE HOLES AT THE THIRD AND FORTH SEGMENT. ONE OF THE HOLES BETWEEN THE SECOND AND THIRD SEGMENT IS RIPPED AND THE OTHER HOLE IS ELONGATED IN THE DIRECTION OF THE AXIS OF THE CANNULA. FROM THE NATURE OF THE RIP AND THE ELONGATION, IT IS POSSIBLE THAT SOMETHING GOT STUCK IN THE HOLES AND RIPPED THE SEGMENTS AWAY FROM THE REST OF THE CANNULA. HOWEVER THE ROOT CAUSE OF THE DAMAGED PRODUCT CANNOT BE DETERMINED. THIS DAMAGE TO THE CANNULA DOES NOT SEEM TO BE A SURGEON ERROR OR A MANUFACTURING NONCONFORMANCE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO NONCONFORMITIES WERE INITIATED FOR LOT 58902340. ALL QD DEVICES ARE 100% INSPECTED PRIOR TO SHIPMENT. EACH CUSTOMER EXPERIENCE REPORT IS THOROUGHLY REVIEWED TO ENSURE APPROPRIATE RISK CONTROL MEASURES ARE IN-PLACE. THE REVIEW OF IN-PROCESS AND FINAL INSPECTION SHOWED THAT ALL CONTROLS WERE IN PLACE AND FUNCTIONING DURING THE MANUFACTURE OF THESE CANNULAE. THE ROOT CAUSE OF THE SEGMENT SEPARATION CANNOT BE DETERMINED. SINCE THIS IS AN ISOLATED INCIDENT A CAPA IS NOT REQUIRED AT THIS TIME. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL TIP OF THE QUICKDRAW CATHETER BROKE OFF INSIDE THE PATIENT. AFTER PATIENT WENT OFF OF PUMP, THE PHYSICIAN BEGAN TO PULL THE CANNULA OUT AND NOTICED "SOMETHING WAS WRONG" THE PATIENT BEGAN BLEEDING. THE TIP MIGRATED IN THE VENOUS SYSTEM AND THE PHYSICIAN HAD TO DO ANOTHER PROCEDURE TO RETRIEVE IT. THERE WAS NO VEIN INJURY TO THE PATIENT. OR STAFF CONFIRMED TO NOT INSPECTING THE DEVICE ASSEMBLY BEFORE USE; THEY HAD NO DIFFICULTY INSERTING THE DEVICE AND THE DEVICE PERFORMED AS EXPECTED (THERE WAS GREAT DRAINAGE DURING THE PROCEDURE). THE OR STAFF REPORTED THAT THIS EVENT DID NOT CAUSE PATIENT HARM AND THEY BELIEVE THE GOT EVERYTHING OUT OF THE PATIENT. PROCEDURE WAS A MINIMALLY INVASIVE MAZE..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKDRAW VENOUS CANNULA VENOUS CANNULAE DWF EDWARDS LIFESCIENCES QD25 58902340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other