MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS UROLUME ENDOPROSTHESIS; STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Burning Sensation (2146); Stenosis (2263); Dysuria (2684)

Event Type  Injury  

Event Description

It was reported by the patient that 13 years after the implantation of a urolume device, the patient experienced "lack of urination and constriction started"."i was born in (b)(6).At 6 years of age, i experienced a fall-related urethral stenosis.Urethra crushing has arrived.I once had open surgery.In 1992, urolume was installed in (b)(6) hospital."the operation went smoothly.Urolume was said to be a new stent.Presence of preoperative stenosis and voiding difficulties were promised to end.I had been discharged home at the end of the hospital, and when i went to check, it was stated that everybody passed perfectly.I do not remember having complications after surgery.Thirteen years after the application of urolume, when the lack of urination and constriction started, the urethra was first opened with the operation called tur to open the urinary tract.The urethra was completely closed after that.A second stent, which was said to be temporary as helpless but unknown to the name of the product, was inserted into the urolume nin.After this procedure, the urinary tract was reopened.For me, however, a troubled process has started for about 10 years.Often, problems such as urinary tract obstruction (most of the sperm are obstructing the urinary tract), excessive burning in the stent area, incontinence are increasing exponentially.I expect information and assistance from you first.I would like you to direct me to a specialist hospital or a urologist who is in charge of the issue for my remedies and problems".This information was provided to the patient liaison for response to the patient.No further patient complications were reported in relation with this event.

• Brand Name: AMS UROLUME ENDOPROSTHESIS
• Type of Device: STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 6933729
• MDR Text Key: 89125416
• Report Number: 2183959-2017-00094
• Device Sequence Number: 1
• Product Code: MES
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability