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 Material Split, Cut or Torn (4008)

Patient Problem No Code Available (3191)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint.The reported allegations could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.

Event Description

It was reported that during a surgical procedure involving a sling the device ripped as the physician ripped when pulling it through the obturator foramen.A new sling was opened to finish the procedure.No information was provided about the patient's outcome.It was further reported that the procedure was extended about ten minutes while a new sling was brought.Patient outcome was said to be unknown at the time.No more information available at the moment.Should additional information become available, it will be provided.

• 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; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 9528486
• MDR Text Key: 175445749
• Report Number: 2183959-2019-68346
• 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: 12/28/2019

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: Health Professional
• Device Model Number: 720163-01
• Device Catalogue Number: 720163-01
• Device Lot Number: 0024311565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR