BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE

    MDR report key: 5002675 · Received August 13, 2015

    Report

    Report Number
    1820334-2015-00491
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Report Date
    July 16, 2015
    Manufacturer
    COOK INC
    Product Code
    DXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    LOT UNKNOWN AS NOT PROVIDED. EXP. DATE UNKNOWN AS NO LOT # WAS PROVIDED. UDI IS UNKNOWN AS NO LOT # WAS PROVIDED. (B)(4). EVENT EVALUATION: A REVIEW OF COMPLAINT HISTORY, DOCUMENTATION, DRAWINGS, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL (QC), AND SPECIFICATIONS WAS CONDUCTED DURING THE INVESTIGATION. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. THE MANUFACTURING AND QC DEPARTMENTS PERFORM A 100% INSPECTION, VERIFYING EACH DEVICE IS FREE FROM BENDS, KINKS, HAS ADEQUATE JOINT STRENGTH, CORRECT OUTSIDE DIMENSION AND OTHER SURFACE IMPERFECTIONS PRIOR TO TRANSPORT. NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. BASED ON THE PROVIDED LEVEL OF INFORMATION A DEFINITIVE ROOT CAUSE CAN NOT BE DETERMINED AT THIS TIME. IT WAS REPORTED THAT THIS INCIDENT RESULTED IN LOW IMPACT TO THE PATIENT. QUALITY ENGINEERING RISK ASSESSMENT WAS USED TO ASSESS THE RISK FOR THIS FAILURE MODE. THE RISK REMAINS ACCEPTABLE AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE USER STATES THAT THEY ARE EXPERIENCING "WIRE BLEEDING", THROMBUS COLLECTING IN THE "J" OF THE WIRE AND THROMBUS COLLECTING ON THE WIRE IN THE SHEATH. THIS HAS HAPPENED ON A NUMBER OF OCCASIONS BUT HAS ONLY BEEN REPORTED ON THIS OCCASION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    THE USER STATES THAT THEY ARE EXPERIENCING "WIRE BLEEDING", THROMBUS COLLECTING IN THE 'J' OF THE WIRE AND THROMBUS COLLECTING ON THE WIRE IN THE SHEATH. THIS HAS HAPPENED ON A NUMBER OF OCCASIONS BUT HAS ONLY BEEN REPORTED ON THIS OCCASION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533443 SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DXQ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1