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

Model Number 720163-02

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Event Description

It was reported that the arms on the advance xp sling device would not clip to the trocar/needle passer.The sling was exchanged for another and worked sufficiently.A patient outcome of no further complications was reported.

Manufacturer Narrative

The advance xp sling was reported to not stay connected to the trocar/needle passer.The advance xp sling, sheath and (2) connectors returned; all units were attached and intact.The connectors were inspected and the inner mold was identified to be damaged on both connectors.It cannot be confirmed as to what this damage is attributed to.The needle passers did not return resulting in an inability to confirm the reported events.Based on this investigation, the investigation conclusion code of cause not established was chosen because the reported events could not be confirmed or substantiated through investigation of the advance xp sling without the return of the complaint needle passers.

Event Description

It was reported that the arms on the advance xp sling device would not clip to the trocar/needle passer.The sling was exchanged for another and worked sufficiently.A patient outcome of no further complications was reported.

• 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: 9695411
• MDR Text Key: 178637578
• Report Number: 2183959-2020-00616
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/04/2020
• Device Model Number: 720163-02
• Device Catalogue Number: 720163-02
• Device Lot Number: 0024612065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Date Manufacturer Received: 02/22/2020
• Patient Sequence Number: 1