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

Model Number 720163-01

Device Problems Premature Activation (1484); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2019

Event Type  Injury  

Event Description

It was reported that during a sling procedure the mesh came unattached with the trocar before getting to the skin surface when the physician tried to pull the sling arms up.One side of the mesh would not reattach to the trocar.The physician used a silk and followed the hole on the sides of the cone connector and then went through the bottom out the top of the cone, used a surgeons knot to adhere to the trocar.A hammer/ richardson tool with a free keith needle was used to go through the cone from bottom to top.The suture worked great.It was also stated that all was good.It was further reported that the patient did not experience any additional adverse events and the sling connection issue did not extend the procedure time significantly.

• 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: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4083953452
• MDR Report Key: 9191421
• MDR Text Key: 163159904
• Report Number: 2183959-2019-66840
• 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: 10/15/2019

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: Health Professional
• Device Expiration Date: 10/12/2019
• Device Model Number: 720163-01
• Device Catalogue Number: 720163-01
• Device Lot Number: 0023196988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR