BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT

    MDR report key: 9454196 · Received December 11, 2019

    Report

    Report Number
    2522007-2019-00027
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 26, 2019
    Report Date
    August 20, 2020
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DWF
    UDI-DI
    00827002264892
    PMA / PMN Number
    K931586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6- EC METHOD CODE DESC - 1: DEVICE NOT RETURNED (4114). H6- EC RESULTS CODE DESC - 1: CHANGED TO NO FINDINGS AVAILABLE (3221). H6- EC CONCLUSIONS CODE DESC - 1: CHANGED TO KNOWN INHERENT RISK OF DEVICE (22). INVESTIGATION-EVALUATION: THE VITAL PORT WAS NOT RETURNED TO CVI, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE CUSTOMER COMPLAINT/EVENT THAT WAS REPORTED IN TRACKWISE: "PORT COULD NOT BE FLUSHED, NO WITHDRAWING POSSIBLE. DSA IS SHOWING A TORN OFF CATHETER AND A LEAKAGE." THE VITAL PORT WAS NOT RETURNED TO CVI, THEREFORE THE QUALITY ASSURANCE DEPARTMENT DID NOT PERFORM A PHYSICAL INVESTIGATION. THE INSTRUCTION FOR USE (IFU) WAS REVIEWED, WHICH LISTS WARNINGS, PLACEMENTS, INDICATIONS ETC.: ""FAILURE TO ADEQUATELY ANCHOR THE PORT TO THE FASCIA INCREASES THE RISK OF CATHETER FRACTURE AND/OR DISCONNECTION WHICH COULD RESULT IN CATHETER MIGRATION.", "DO NOT PLACE SUTURES ON CATHETER, AS CATHETER MAY BE COMPROMISED.", "DO NOT EXCEED THE MAXIMUM FLOW RATE; DOING SO MAY RESULT IN SEPTUM LEAKAGE, CATHETER DISPLACEMENT AND/OR SYSTEM FAILURE." , "DO NOT EXCEED THE MAXIMUM PRESSURE; DOING SO MAY RESULT IN SEPTUM LEAKAGE, CATHETER DISPLACEMENT AND/OR SYSTEM FAILURE." , "FAILURE TO ENSURE PATENCY OF THE CATHETER LUMEN PRIOR TO INJECTION MAY RESULT IN CATHETER FAILURE." , "AVOID CONTACTING THE CATHETER WITH SHARP OBJECTS WHICH MAY LEAD TO CATHETER SHEARING." , "IMPROPER CATHETER CONNECTION MAY RESULT IN CATHETER DAMAGE, LEAKAGE, OR POSSIBLE DISCONNECTION. PRIOR PRACTICE IS RECOMMENDED TO ENSURE DEXTERITY IN CONNECTION THE CATHETER TO THE PORT. HOWEVER, DO NOT PRACTICE WITH A CATHETER INTENDED FOR IMPLANTATION; DOING SO MAY RESULT IN DAMAGE TO THE CATHETER." AND "USE OF THE VITAL-PORT SYSTEM INVOLVES POTENTIAL RISKS NORMALLY ASSOCIATED WITH THE INSERTION OR USE OF ANY IMPLANTED DEVICE OR INDWELLING CATHETER. THESE INCLUDE, BUT NOT LIMITED TO: ¿¿.CATHETER DISCONNECTION, FRACTURE, FRAGMENTATION....". WITHOUT THE DEVICE TO PHYSICALLY INVESTIGATE; A DEFECT OR MALFUNCTION OF THE DEVICE OR THE MANUFACTURING PROCESS IS INCONCLUSIVE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A COOK VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT (IP-S5116W-MPIS-NT) COULD NOT BE FLUSHED, NO WITHDRAWING POSSIBLE. THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) IS SHOWED A TORN OFF CATHETER AND A LEAKAGE WITHIN THE REMAINING CATHETER PART, CLOSE TO THE PORT CHAMBER. THE PORT AND CATHETER WERE EXPLANTED / REMOVED, NO SECTION OF THE DEVICE REMAINED IN THE PATIENT. IT WAS ALSO NOTED THAT NO PRODUCT IS AVAILABLE FOR EXAMINATION BY MANUFACTURER. AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). MANUFACTURE OF THIS DEVICE WAS DISCONTINUED IN NOVEMBER 2017. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COOK VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT (IP-S5116W-MPIS-NT) COULD NOT BE FLUSHED, NO WITHDRAWING POSSIBLE. THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) IS SHOWED A TORN OFF CATHETER AND A LEAKAGE WITHIN THE REMAINING CATHETER PART, CLOSE TO THE PORT CHAMBER. THE PORT AND CATHETER WERE EXPLANTED / REMOVED, NO SECTION OF THE DEVICE REMAINED IN THE PATIENT. IT WAS ALSO NOTED THAT NO PRODUCT IS AVAILABLE FOR EXAMINATION BY MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244609 VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF COOK VANDERGRIFT INC G26489 N135693 00827002264892

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention