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

Model Number 720163-01

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2019

Event Type  malfunction  

Event Description

It was reported that during implant the mesh ripped when the physician pulled back on the sling arm from the perineal incision with an advance xp sling.The sling was explanted and a new advance xp was implanted.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

• Brand Name: AMS ADVANCE XP SLING SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: mike bocchino ; 10700 bren road w; minnetonka, MN 55343 ; 6515827161
• MDR Report Key: 8620499
• MDR Text Key: 145396948
• Report Number: 2183959-2019-63173
• Device Sequence Number: 1
• Product Code: OTM
• UDI-Device Identifier: 00878953005560
• UDI-Public: 00878953005560
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/02/2020
• Device Model Number: 720163-01
• Device Catalogue Number: 720163-01
• Device Lot Number: 0023458626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR