BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 11446578 · Received March 9, 2021

    Report

    Report Number
    2210968-2021-02138
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    January 1, 2009
    Report Date
    March 1, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: UROLOGY. 2009 OCT; CONFERENCE: 30TH CONGRESS OF THE SOCIETIES INTERNATIONALE D'UROLOGIE, SIU 2009.SHANGHAI CHINA. SPONSOR: SIU. CONFERENCE PUBLICATION: (VAR.PAGINGS). 74 (4 SUPPL S): S224.

    Description of Event or Problem · 1

    TITLE: A LOOPED PROLENE SUTURE STENT AS AN AID IN TREATMENT RECURRENT URETHRAL STRICTURE THIS STUDY PRESENTS A TECHNIQUE TO PREVENT REOPERATION TO CORRECT THE RECURRENT URETHRAL STRICTURE WHICH IS DIFFICULT FROM PREVIOUS SCAR AND THE TREATMENT BY URETHRAL DILATION OR INTERNAL URETHROTOMY THAT MAY HAVE COMPLICATIONS SUCH AS FALSE TRACT OR RECTAL INJURY. BETWEEN JANUARY 1999 AND MARCH 2009, 51 PATIENTS (MEAN OF 35 WITH A RANGE OF 15 TO 67) WITH URETHRAL STRICTURE UNDERWENT URETHROPLASTY (82%) OR INTERNAL URETHROTOMY (18%). ALL PATIENTS HAD SUPRAPUBIC CYSTOSTOMY BEFORE TREATMENT. A PROLENE SUTURE (ETHICON) WAS PLACED IN THE TIP OF URETHRAL CATHETER AND PULLS THE END OF THE SUTURE THROUGH SUPRAPUBIC CYSTOSTOMY TRACT. WHEN THE URETHRAL CATHETER WAS REMOVED, THE PROLENE SUTURE (ETHICON) WAS TIED AS A LOOP AND LEFT IN URETHRAL LUMEN AS A STENT. IN CASES WITH RECURRENT URETHRAL STRICTURE, THE STRICTURE WAS DILATED BY VISUAL DILATION WITH RIGID CYSTOSCOPE OR BY-PASSING FASCIAL DILATOR OVER THE PROLENE SUTURE (ETHICON). WHEN THE INTERNAL URETHROTOMY WAS PERFORMED FOR TREATMENT RECURRENT STRICTURE, URETERAL CATHETER WAS INSERTED THROUGH THE PROLENE SUTURE (ETHICON) AND THE GUIDE WIRE WAS REPLACED. CATHETER WAS REMOVED AT 2-4 WEEKS (MEDIAN 3 WEEKS) AND THE TIME OF RETAINED PROLENE SUTURE (ETHICON) STENT WAS 1-16 MONTH (MEAN 4.5 MONTHS). POSTERIOR URETHRAL DISRUPTION DEFECTS (N=31) AND ANTERIOR URETHRAL STRICTURE (N=21) WERE REPORTED. STRICTURE RECURRED (N=17) (33%) AND WAS MANAGED BY VISUAL DILATION OR FASCIAL DILATOR IN 14 CASES AND INTERNAL URETHROTOMY IN 3 CASES. TWO PATIENTS NEED REINSERTED SUPRAPUBIC CYSTOSTOMY TUBE. IN CASE OF RECURRENT URETHRAL STRICTURE, THE PROLENE SUTURE STENT CAN GUIDE DIRECTION OF URETHRAL LUMEN AND MAY BE USED FOR REINSERTED SUPRAPUBIC CYSTOSTOMY TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340685 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention