BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS W/9FR INTR KIT LW PFL

    MDR report key: 6218236 · Received January 3, 2017

    Report

    Report Number
    1219930-2017-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2017
    Date of Event
    November 30, 2016
    Report Date
    November 1, 2017
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    LJT
    PMA / PMN Number
    K952748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL ATTEMPTS TO OBTAIN INFORMATION AND THE DEVICE HAVE BEEN MADE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH NEW DETAILS IF THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE REPORTED CONDITION WAS PERFORMED. ONE SAMPLE WITH APPROPRIATE PACKAGING WAS RECEIVED FOR THE EVALUATION. THE RETURNED SAMPLE WAS VISUALLY INSPECTED WHICH INDICATED NO OBSTRUCTIONS OR DAMAGE TO THE SHEATH AND THERE WERE NO VISUAL ABNORMALITIES IN THE PRODUCT. AFTER EVALUATION OF SAMPLE WITH FUNCTIONAL TESTING THE GUIDE WIRE WAS EASILY ABLE TO BE INSERTED AND REMOVED WITHOUT ANY DAMAGE TO THE SHEATH OR THE WIRE. THE REPORTED CONDITION WAS NOT CONFIRMED. THE REVIEW OF DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED AS THERE WAS NO ASSEMBLY COMPONENT RELATED ISSUES. DURING THE TIME OF MANUFACTURING, THE RECORDS OF EACH LOT WAS THOROUGHLY REVIEWED TO MAKE SURE THAT THE PRODUCT RELEASED IS MEETING THE QUALITY RELEASE SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED CONDITION INDICATED THAT NO ENHANCEMENTS OR IMPROVEMENTS WERE MADE TO THE REPORTED CONDITION. NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME. SHOULD THE CUSTOMER PROVIDE WITH ADDITIONAL INFORMATION THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A PORT IMPLANT PROCEDURE, THE GUIDEWIRE COULDN'T INSERT THE DILATOR-SHEATH ASSEMBLY. THE PATIENT IS STABLE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    THE GUIDEWIRE COULDN'T INSERT THE DILATOR-SHEATH ASSEMBLY. "WHEN WAS THE PROBLEM NOTICED: DURING-PROCEDURE (PORT A IMPLANTATION)", PATIENT INVOLVEMENT: YES; PATIENT INJURY: NO; PATIENT INFORMATION: N/A; "WHAT IS THE CURRENT CONDITION OF THE PATIENT: STABLE." MEDICAL INTERVENTION REQUIRED: NO; "WAS SURGERY TIME EXTENDED BY 30 MINS OR MORE: NO, WAS PRODUCT TESTED PRIOR TO USE: NO, CAN YOU CONFIRM THAT PRODUCT IS AVAILABLE AND WILL BE RETURNED FOR EVALUATION: YES." THE PRODUCT WILL BE RETURNED. " WHAT SURGICAL PROCEDURE WAS BEING PERFORMED: PORT IMPLANTATION, DID THE USER EXPERIENCE DIFFICULTY INSERTING THE DEVICE INTO THE PATIENT: NO, WHAT WAS DONE TO CORRECT THE CONDITION: TO OPEN ANOTHER NEW ONE TO COMPLETE THE PROCEDURES, WAS THERE ANY UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM: NO, WAS THERE ANY TISSUE DAMAGE AS A RESULT OF THIS PROBLEM: NO, WAS THERE BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3591 2PC VSYS W/9FR INTR KIT LW PFL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT COVIDIEN, FORMERLY US SURGICAL A DIVISON 120021 N3E0092X

    Patients

    Seq Age Sex Outcome Treatment
    1