BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15033284 · Received July 15, 2022

    Report

    Report Number
    2210968-2022-05572
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    March 25, 2022
    Report Date
    July 15, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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. (B)(4). CITATION: UROLOGY CASE REPORTS (2022);43:10207. HTTPS://DOI.ORG/10.1016/J.EUCR.2022.102071.

    Description of Event or Problem · 0

    TITLE: RETURN TO URINARY CONTINENCE AND SEXUAL FUNCTION AFTER PELVIC FRACTURE-URETHRAL INJURY ¿ A YOUNG WOMAN¿S YEARS-LONG JOURNEY. THIS STUDY REPORTS A CASE OF A 24-YEAR-OLD FEMALE BICYCLIST INVOLVED IN A TRAUMATIC COLLISION WITH A TRUCK SUFFERED COMPLEX PELVIC FRACTURES WITH ASSOCIATED BLADDER INJURY AND COMPLETE AVULSION OF HER BLADDER NECK-PROXIMAL URETHRA COMPLEX, FOR WHICH CYSTORRHAPHY AND SUPRAPUBIC TUBE (SPT) DRAINAGE WERE REQUIRED. SURGERY WAS PERFORMED APPROXIMATELY TWO YEARS AFTER THE INITIAL TRAUMA. THE PROXIMAL URETHRA WAS ANASTOMOSED TRANSVAGINALLY TO THE NEWLY PATENT BLADDER NECK AROUND A 14F FOLEY CATHETER WITH CLOSELY SPACED INTERRUPTED VICRYL SUTURES. REPORTED COMPLICATIONS WERE: AT ONE-MONTH FOLLOW-UP, URETHROSCOPY DEMONSTRATED A SMALL VENTRAL ANASTOMOTIC DISRUPTION, PRESUMABLY DUE TO PRESSURE FROM THE URETHRAL CATHETER. THE SPT WAS EXCHANGED AND THE URETHRAL CATHETER REMOVED TO FACILITATE HEALING OF THE VENTRAL DEFECT. ONE MONTH LATER, URETHROSCOPY REVEALED A STENOTIC URETHRAL RECONSTRUCTION THROUGH WHICH THE 18F FLEXIBLE CYSTOSCOPE COULD NOT PASS, AND A PERSISTENT FISTULA. DESPITE THESE FINDINGS, THE PATIENT HAD NO VOIDING COMPLAINTS AND THUS ELECTED CONSERVATIVE MANAGEMENT. UNFORTUNATELY, SPT CAP TRIALS REVEALED SUBJECTIVELY HIGH PVRS WHICH DID NOT IMPROVE OVER TIME. IN THE FOURTH POST-OPERATIVE MONTH WE PERFORMED URETHRAL DILATION LEAVING A 14F URETHRAL CATHETER IN PLACE FOR ONE WEEK, AND THEN RESUMED SPT CAP TRIALS. THREE WEEKS AFTER DILATION, URETHROSCOPY WITH AN 8F SCOPE REVEALED A MATURED URETHRAL SCAR WITH A 12F LUMEN, AND REDEMONSTRATED THE SMALL MATURED URETHROVAGINAL FISTULA. THE SPT WAS REMOVED LEAVING THE PATIENT COMPLETELY CATHETER-FREE AND VOIDING WITHOUT DIFFICULTY. THE FISTULA REMAINED ASYMPTOMATIC. THE PATIENT RETURNED FOR EVALUATION 19 MONTHS AFTER HER INDEX OPERATION. DURING THAT TIME SHE REPORTED HAVING FULL URINARY CONTINENCE WITH ONLY A MINIMAL DECREASE IN THE CALIBER OF THE URINARY STREAM DUE TO THE STRICTURE, AND A SUCCESSFUL RETURN TO PENETRATIVE VAGINAL INTERCOURSE. ON CYSTOSCOPY THE ANASTOMOSIS EASILY PERMITTED PASSAGE OF AN 8F PEDIATRIC CYSTOSCOPE, AND THE BLADDER APPEARED COMPLETELY NORMAL. THE URETHROVAGINAL FISTULA PERSISTED, HOWEVER SHE REMAINED ASYMPTOMATIC AND ELECTED FOR CONTINUED CONSERVATIVE MANAGEMENT. AT HER FINAL FOLLOW-UP VISIT ALMOST THREE YEARS AFTER THE INDEX OPERATION THE PATIENT REMAINED FULLY CONTINENT OF URINE AND EXPRESSED WISHES TO AVOID ANY FURTHER PROCEDURES, COMPLETELY SATISFIED WITH THE RESULTS OF HER SURGERY. IN CONCLUSION, TRAUMATIC URETHRAL INJURIES IN FEMALES ARE UNCOMMON AND MAY BE UNDERDIAGNOSED SINCE THEY TYPICALLY OCCUR IN CONCERT WITH MORE PRESSING INJURIES. IT IS ESSENTIAL TO HAVE A HIGH INDEX OF SUSPICION FOR THESE INJURIES AND TO ACTIVELY SEEK THEM OUT WHEN THERE IS BLOOD AT THE INTROITUS, DIFFICULTY WITH CATHETER PASSAGE, OR ABSENCE OF DRAINAGE FROM THE URINARY CATHETER. IN OUR PATIENT, DELAYED PRIMARY REPAIR VIA A COMBINED TRANSABDOMINAL AND TRANS-VAGINAL APPROACH RESULTED IN A SUCCESSFUL RETURN TO SUSTAINED URINARY CONTINENCE AND NORMAL SEXUAL FUNCTION, DESPITE THE DEVELOPMENT OF A SMALL BUT PERSISTENT URETHROVAGINAL FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2872360 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention