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

Model Number UNK-P-SLING-MENS ADVANCE XP

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 04/02/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced a urethral injury during the original implantation of an advance xp sling.The injury occurred during trocar advancement on the patient's left side.The urethral injury was observed under cystoscopy during the tensioning step of sling placement.The physician sutured the urethral defect, successfully implanted the advance xp sling, and then closed the perineal incision using a multilayer closure technique.No further complications were reported in relation to this event.Should additional information be received, a supplemental report will be filed.

Event Description

It was reported that the patient experienced a urethral injury during the original implant of an advance xp sling.The injury occurred during trocar advancement on the patient's left side.The urethral injury was observed under cystoscopy during the tensioning step of sling placement.The physician sutured the urethral defect, successfully implanted the advance xp sling, and then closed the perineal incision using a multilayer closure technique.No further complications were reported in relation to this event.Should additional information be received, a supplemental report will be filed.

• 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: 8546624
• MDR Text Key: 142965850
• Report Number: 2183959-2019-62523
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• PMA/PMN Number: K182169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK-P-SLING-MENS ADVANCE XP
• Device Catalogue Number: UNK-P-SLING-MENS ADVANCE XP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 06/04/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR