BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS

    MDR report key: 1942553 · Received December 30, 2010

    Report

    Report Number
    3005099803-2010-05390
    Event Type
    Injury
    Date Received
    December 30, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER IS NOT KNOWN PER COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A PATIENT HAD RECURRENT INFECTIONS OVER A PERIOD OF FOUR YEARS. A COMPUTED TOMOGRAPHY (CT) SCAN WAS COMPLETED AND THE RESULTS REVEALED A FOREIGN OBJECT IDENTIFIED AS A FLEXIMA STENT SUTURE WITH EDEMA AND SCARRING ATTACHED. IT IS UNCONFIRMED IF THE SUTURE WAS REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA STENT WAS USED IN AN UNKNOWN PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN REPORTED AN "ISSUE" WITH THE DEVICE ON 4 SEPARATE OCCASIONS. PATIENT INFORMATION IS UNAVAILABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A PATIENT HAD RECURRENT INFECTIONS OVER A PERIOD OF FOUR YEARS. A COMPUTED TOMOGRAPHY (CT) SCAN WAS COMPLETED AND THE RESULTS REVEALED A FOREIGN OBJECT IDENTIFIED AS A FLEXIMA STENT SUTURE WITH EDEMA AND SCARRING ATTACHED. IT IS UNCONFIRMED IF THE SUTURE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER UNK144

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R