BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEANER 7F X 65CM 15MM

    MDR report key: 5637990 · Received May 6, 2016

    Report

    Report Number
    1625425-2016-00010
    Event Type
    Injury
    Date Received
    May 6, 2016
    Date of Event
    April 4, 2016
    Report Date
    May 5, 2016
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    KRA
    PMA / PMN Number
    K141617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INJURY. THE DOCTOR DID NOT TAKE THE TIP OUT OF THE VESSEL OF THE PATIENT. PER THE INFORMATION RECEIVED, HE SECURED THE BROKEN TIP USING A STENT. THE STENT WAS EXPANDED AND EVERYTHING PUSHED AGAINST THE WALL OF THE VESSEL WHICH WOULD KEEP THE TIP FROM MIGRATING AND KEEP THE FISTULA PATENT. THE PRODUCT WAS MANUFACTURED BY(B)(4) WHICH WAS ACQUIRED BY (B)(4) IN DECEMBER 2015. THE MANUFACTURING DHR REVIEW WAS CONDUCTED BY (B)(4), ONE OF THE SUBCONTRACTORS, AND NO DEVIATIONS OR NONCONFORMANCES WERE NOTED. THE DEVICE WAS RETURNED FOR EVALUATION AND AS STATED IN THE COMPLAINT, THE POLYMER TIP HAD DETACHED FROM THE DEVICE; HOWEVER,THE METAL TIP APPEARED INTACT. THE POLYMER TIP WAS NOT RETURNED. ACCORDING TO (B)(4) REVIEW OF THE PHOTOGRAPHS OF THE TIP, THE APPEARANCE OF THE TIP WAS NOT CONSISTENT WITH THE DRAWING, AS IT DID NOT EXHIBIT CLEAR FLAT AREAS WHICH WOULD ALLOW THE TIP TO CATCH WHEN GIVEN PULL. A DEFINITIVE ROOT CAUSE OF THE DETACHMENT OF THE TIP WAS NOT DETERMINED. IT IS POSSIBLE THAT THE TIP WAS NOT MACHINED CORRECTLY WHICH WOULD HAVE REDUCED THE FORCE NEEDED TO REMOVE THE SOFT TIP, BUT TENSILE FORCE WOULD STILL BE NEEDED FOR DETACHMENT TO OCCUR. FIBROUS TISSUE WAS FOUND WRAPPED AROUND THE TIP OF THE RETURNED DEVICE, SO IT IS POSSIBLE THAT THE TIP BECAME ENTANGLED IN SUCH TISSUE, AND THE FORCE WAS APPLIED, REMOVING THE SOFT POLYMER TIP. DESIGN CHANGES TO THE TIP WERE MADE TO THIS PRODUCT LINE IN 2014 TO PREVENT FUTURE INSTANCES OF TIP DETACHMENT. THE COMPLAINT LOT WAS MANUFACTURED IN JUNE 2013. THERE HAVE BEEN NO OTHER RELATED COMPLAINTS FOR THIS PART NUMBER SINCE THIS COMPLAINT.

    Description of Event or Problem · 1

    WHILE USING CLEANER IN FISTULA DISTAL TIP CAME OFF INSIDE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291472 CLEANER 7F X 65CM 15MM CLEANER KRA ARGON MEDICAL DEVICES, INC. 1300141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention