BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA CATHETER

    MDR report key: 1933447 · Received December 20, 2010

    Report

    Report Number
    2134265-2010-05828
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE THREAD BLOCKED THE REMOVAL OF THE DELIVERY SYSTEM. THE PHYSICIAN NOW STATES THE SUTURE DID NOT BREAK, IT ONLY BLOCKED THE REMOVAL OF THE DELIVERY SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS DRAINAGE PROCEDURE THE SUTURE BROKE. THE ANATOMY LOCATION WAS IN THE BILIARY TREE. THE PHYSICIAN USED A FLEXIMA BILIARY 8F/35CM DRAIN. THE PHYSICIAN STATED THE "THREAD FAILED" DUE TO THE SUTURE BREAKING. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE DEVICE. THE PATIENT IS STATED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA CATHETER TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - SPENCER M001271650

    Patients

    Seq Age Sex Outcome Treatment
    1