BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER, 7F, 100CM

    MDR report key: 4200237 · Received October 24, 2014

    Report

    Report Number
    2183870-2014-00265
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    COVIDIEN-PLYMOUTH
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN.  A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE CLOSUREFAST CATHETER WAS RECEIVED FOR EVALUATION WITHOUT ANY ANCILLARY DEVICES OR SONOGRAM IMAGES FROM THE PROCEDURE. THE CATHETER WAS RETURNED IN ITS TRANSPORTATION TRAY WITH LID AND PACKED WITHIN ITS SHELF CARTON. THE CATHETER WAS EXAMINED: FIVE KINKS WERE NOTED AND A BEND IN THE COIL PORTION OF THE CATHETER WAS NOTED. TWO OF THE KINKS WERE NOTED TO BE IN AREAS NEAR STANDOFFS IN THE TRANSPORTATION TRAY. THE CONNECTOR WAS EXAMINED: PINS ARE STRAIGHT. THE CATHETER DID PASS CONTINUITY AND RESISTANCE FUNCTIONAL TESTING: E+ TO E- 89.1OHMS (80OHMS TO 113OHMS). CONTINUITY AND RESISTANCE FUNCTIONAL PASSING TESTING RESULTS: TC+ TO TC- 159.2OHMS (LESS THAN OR EQUAL TO 250OHMS), RESISTOR 1 VALUE 13.75KOHMS (13.43KOHMS TO 13.97KOHMS), AND RESISTOR 2 VALUE 8.08KOHMS (7.90KOHMS TO 8.22KOHMS). THE CATHETER PASSED FUNCTIONAL TESTING: PROPER DEVICE RECOGNIZED BY RFG2 WHEN PLUGGED IN, LOW TEMPERATURE ADVISORY DISPLAYED WHEN ACTIVATED, WHEN ACTIVATED CYCLE STARTS WITHOUT ADVISORY MESSAGE, TEMPERATURE RISES TO 120C, AND DEVICE COMPLETES CYCLE WITHOUT ADVISORY MESSAGES. THE CATHETER PASSED FUNCTIONAL TESTING USING A WET TOWEL TIGHTLY WRAPPED AROUND THE COIL. A TOWEL HEATED IN SALINE AND WRAPPED AROUND THE COIL GENERATED THE ADVISORY MESSAGE OF: TREATMENT HALTED: NON-UNIFORM TEMPERATURE. ADJUST COMPRESSION ALONG HEATING ELEMENT. EIGHT SECONDS WITHIN TARGET TEMPERATURE RANGE. PRESSURE WAS APPLIED TO THE HEATED SALINE SOAKED TOWEL WRAPPED AROUND THE COIL AND THE CATHETER PASSED FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CATHETER WAS PLUGGED INTO THE RF GENERATOR AND INSERTED INTO THE PATIENT THAT WAS TREATED WITH TUMECENT ANESTHESIA. THE CATHETER DID NOT SHOW A SIGNIFICIANCT TEMPERATURE CHANGE ON SECOND SEGMENT. COMPRESSION WAS ADJUSTED AND AGAIN THE TEMPERATURE OF 120 CELICIOUS WAS NOT MET. VISUAL DAMAGE WAS SEEN ON THE CATHETER WHEN PHYSICIAN PULLED IT OUT TO INSPECT IT. THE PROCEDURE ABORTED BECAUSE PATIENT HAD THE MAX DOSAGE OF LIDOCANE AND ADDITIONAL TUMESCENT ANESTHESIA WAS NEEDED TO COMPRESS THE VEIN WALL TO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680217 CLOSUREFAST CATHETER, 7F, 100CM ELECTROSURGICAL, CUTTING, & COAGULATION & ASSCESSORIES GEI COVIDIEN-PLYMOUTH CF7-7-100 552477X

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other