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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
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BOSTON SCIENTIFIC CORPORATION AMS ADVANCE SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE Back to Search Results
Model Number UNK-P-SLING-MENS_ADVANCE
Device Problem Insufficient Information (3190)
Patient Problem Urinary Incontinence (4572)
Event Date 10/17/2022
Event Type  Injury  
Event Description
It was reported that the patient had a sling device implanted.During ongoing use of the sling device, the patient experienced recurring incontinence and underwent a surgical procedure to implant a new artificial urinary sphincter (aus) device.There were no additional patient complications.
 
Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom of incontinence is a known risk associated with implant of these devices as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
Event Description
It was reported that the patient had a sling device implanted.During ongoing use of the sling device, the patient experienced recurring incontinence and underwent a surgical procedure to implant a new artificial urinary sphincter (aus) device.There were no additional patient complications.
 
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Brand Name
AMS ADVANCE SLING SYSTEM
Type of Device
MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key15672343
MDR Text Key302399060
Report Number2124215-2022-43632
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K053371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/01/2022
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? No
Device Operator Lay User/Patient
Device Model NumberUNK-P-SLING-MENS_ADVANCE
Device Catalogue NumberUNK-P-SLING-MENS_ADVANCE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/17/2022
Initial Date FDA Received10/26/2022
Supplement Dates Manufacturer Received11/16/2022
Supplement Dates FDA Received12/01/2022
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 Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age81 YR
Patient SexMale
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