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

Model Number	720088-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, when the physician tried to pass the needle unto the sling it broke away.The device was unable to be used and a new sling device had to opened for backup.There were no patient adverse effects in relation to this event.

• Brand Name: AMS ADVANCE MALE SLING SYSTEM
• Common Device Name: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8921287
• Report Number: 2183959-2019-65798
• Device Sequence Number: 19308731
• Product Code: OTM
• UDI-Device Identifier: 00878953005300
• UDI-Public: 00878953005300
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 720088-01
• Device Catalogue Number: 720088-01
• Device Lot Number: 1000289328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/22/2019
• Patient Sequence Number: 1