MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE

Model Number UNK-P-SLING-MENS

Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190)

Patient Problem Incontinence (1928)

Event Date 11/12/2018

Event Type  Injury  

Event Description

It was reported that the patient underwent a surgical procedure during which this artificial urinary sphincter (aus) was explanted due to recurring incontinence.It was noted the patient also had a bladder sling in addition to the chronic aus; there was no reported revision of the sling.No adverse patient effects were reported.The explanted components are not expected for return.A supplemental report will be filed should additional information received, or the device returned for analysis.

Manufacturer Narrative

Date of event updated.Describe event or problem updated.Device codes updated.

Event Description

It was reported that the patient underwent a surgical procedure during which this artificial urinary sphincter (aus) was explanted due to recurring incontinence resulting from a cuff leak.It was noted the patient also had a bladder sling in addition to the chronic aus; there was no reported revision of the sling.No adverse patient effects were reported.The explanted components are not expected for return.A supplemental report will be filed should additional information received, or the device returned for analysis.

• Brand Name: AMS SLING SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8646037
• MDR Text Key: 146236935
• Report Number: 2183959-2019-63463
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-SLING-MENS
• Device Catalogue Number: UNK-P-SLING-MENS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 06/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR