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 Defective Device (2588); Connection Problem (2900)

Patient Problem No Code Available (3191)

Event Date 07/30/2019

Event Type  Injury  

Event Description

It was reported that during a surgical procedure involving the implant of a sling device, it would not "stay snapped" to tip of trocar for passing under the skin.A second sling device was opened and used.The patient was reported to be stable after the surgical procedure.No more information available at the moment, further information was requested.Additional information was received in which it was stated that the patient experienced issues with the second sling device.Procedure time was extended due to the issues with both sling placement attempts.

Event Description

It was reported that during a surgical procedure involving the implant of a sling device, it would not "stay snapped" to tip of trocar for passing under the skin.A second sling device was opened and used.The patient was reported to be stable after the surgical procedure.No more information available at the moment, further information was requested.Additional information was received in which it was stated that the patient experienced issues with the second sling device.Procedure time was extended due to the issues with both sling placement attempts.

Event Description

It was reported that during a surgical procedure involving the implant of a sling device, it would not "stay snapped" to tip of trocar for passing under the skin.A second sling device was opened and used.The patient was reported to be stable after the surgical procedure.No more information available at the moment, further information was requested.Additional information was received in which it was stated that the patient experienced issues with the second sling device.Procedure time was extended due to the issues with both sling placement attempts.

Manufacturer Narrative

Device analysis: product investigation completed.As the sling was not returned for analysis, the reported allegations could not be confirmed.The event cannot be reproduced or substantiated.However, similar complaint review revealed previous complaints were determined to be due to a dilator short shot which created molded part imperfections.The parts in relation to this complaint were confirmed to have been produced on the older tool 07156, which experienced partial issues.

• 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
• MDR Report Key: 8904519
• MDR Text Key: 154688780
• Report Number: 2183959-2019-65716
• Device Sequence Number: 1
• Product Code: OTM
• UDI-Device Identifier: 00878953005560
• UDI-Public: 00878953005560
• 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,Followup
• 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: 03/13/2020
• Device Model Number: 720163-01
• Device Catalogue Number: 720163-01
• Device Lot Number: 0023860807
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/18/2019
• Supplement Dates Manufacturer Received: 07/30/2019; 09/30/2019
• Supplement Dates FDA Received: 08/19/2019; 10/15/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR