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 07/30/2019

Event Type  Injury  

Event Description

It was reported that during a sling device implant procedure, after issues with another sling due to it not fixating correctly, a second sling device was opened and implanted.However, the arms of the device tore on both sides prior to the removal of tyvex sheaths during tensioning under cysto.When the arms tore off, partial arm and mesh were left sutured to the urethra and still in the body.It was also indicated that the procedure time was extended due to issues with two sling placements.The physician updated that the patient voided post procedure and will follow up in office.No more information available at the moment, further information was requested.It was further clarified that the second sling device remained implanted.The patient was said to be stable after the procedure.

Manufacturer Narrative

D6, d7, h2, h10 updated.

Event Description

It was reported that during a sling device implant procedure, after issues with another sling due to it not fixating correctly, a second sling device was opened and implanted.However, the arms of the device tore on both sides prior to the removal of tyvex sheaths during tensioning under cysto.When the arms tore off, partial arm and mesh were left sutured to the urethra and still in the body.It was also indicated that the procedure time was extended due to issues with two sling placements.The physician updated that the patient voided post procedure and will follow up in office.No more information available at the moment, further information was requested.It was further clarified that the second sling device remained implanted.The patient was said to be stable after the procedure.

• 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: 8904521
• MDR Text Key: 154691170
• Report Number: 2183959-2019-65717
• 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
• Report Date: 08/19/2019

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
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/18/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/19/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR