BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE HYDROPHILIC GUIDE WIRE

    MDR report key: 2972824 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00920
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EVALUATION/FINDINGS: AS RECEIVED, THE SPECIMEN APPEARS VISUALLY AND DIMENSIONALLY CORRECT. THE SPECIMEN PRESENTS A LARGE RADIUS, TWISTING BEND OVER THE DISTAL 6.5CM, CONSISTENT WITH TENSILE LOADING AND A BEND OVER THE PROXIMAL 2MM. THE SPECIMEN COATING APPEARS VISUALLY AND TACTILELY CONSISTENT. MICROSCOPICALLY THE SPECIMEN COATING APPEARS TO BE SMOOTH AND CONSISTENT WITH EXTENSIVE REGIONS OF WEAR/ABRASION WITH DRIED BLOOD-LIKE MATERIAL RESIDUE WITHIN THE COATING, AS INDICATED BY THE TRANSFER TO THE WETTING WIPE. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARS VISUALLY AND DIMENSIONALLY CORRECT. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2013-00921. IT WAS REPORTED THAT DURING A ABDOMINAL AORTIC ANEURYSM REPAIR THERE WERE DIFFICULTIES REMOVING THE SHEATH. THERE WAS A 6F, 9F, 12F, TWO 14F AND A 18F SUPER SHEATHS USED DURING THE PROCEDURE. ONE OF THE 14F SHEATHS WAS UNABLE TO ENTER THE PATIENT'S BODY. THE SECOND 14F SUPER SHEATH, THEY WERE UNABLE TO LOOSEN THE DILATOR OF THE SHEATH AND EXPERIENCED DIFFICULTIES REMOVING FROM THE PATIENT. THE HYDROPHILIC COATING CAME OFF OF THE ZIPWIRE. THE PROCEDURE WAS COMPLETED USING THE 18F SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2013-00921. IT WAS REPORTED THAT DURING A ABDOMINAL AORTIC ANEURYSM REPAIR THERE WERE DIFFICULTIES REMOVING THE SHEATH. THERE WAS A 6F, 9F, 12F, TWO 14F AND A 18F SUPER SHEATHS USED DURING THE PROCEDURE. ONE OF THE 14F SHEATHS WAS UNABLE TO ENTER THE PATIENT'S BODY. THE SECOND 14F SUPER SHEATH, THEY WERE UNABLE TO LOOSEN THE DILATOR OF THE SHEATH AND EXPERIENCED DIFFICULTIES REMOVING FROM THE PATIENT. THE HYDROPHILIC COATING CAME OFF OF THE ZIPWIRE. THE PROCEDURE WAS COMPLETED USING THE 18F SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76988 ZIPWIRE HYDROPHILIC GUIDE WIRE WIRE, GUIDE, CATHETER DQX LAKE REGION MEDICAL M00146154B0

    Patients

    Seq Age Sex Outcome Treatment
    1