BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA¿ APDL

    MDR report key: 2762929 · Received September 27, 2012

    Report

    Report Number
    2134265-2012-05843
    Event Type
    Injury
    Date Received
    September 27, 2012
    Report Date
    August 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OF AGE OR OLDER. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE, THE CATHETER HAD DIFFICULTY ADVANCING AND THE PATIENT EXPERIENCED BLEEDING. A NON-BSC SUPER STIFF GUIDE WIRE WAS INTRODUCED AND ADVANCED TO THE KIDNEY. THE PIGTAIL LOCK WAS STRAIGHTENED AND THE APDL/8 FLEXIMA DRAINAGE CATHETER INTRODUCED OVER THE WIRE. THE CATHETER BECAME STUCK IN THE CHANNEL AND BUCKLED. THE CATHETER WAS REMOVED AND A 10F DILATOR WAS INSERTED TO OPEN UP THE CHANNEL. THE CATHETER WAS REINSERTED SUCCESSFULLY AND THE GUIDE WIRE REMOVED. WHEN THE DRAINAGE BAG WAS ATTACHED TO THE END OF THE HUB, BLOOD WAS SEEN IN THE BAG RATHER THAN CLEAR FLUID. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THE PHYSICIAN STATED THAT DURING PREPARATION, THE FLEXIMA WAS NOT PRE-SOAKED FOR 30 SECONDS AS MENTIONED IN THE DFU, BUT WAS WET 'AS HE ALWAYS HAS DONE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA¿ APDL TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001271340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other