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 Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 11/13/2020

Event Type  Injury  

Event Description

It was reported that an unspecified sling was implanted on an unspecified date.An artificial urinary sphincter (aus) device was later implanted due to unspecified reasons.

Manufacturer Narrative

Investigation summary: based on the information available, there was no device available for analysis.The reported patient symptom of recurring incontinence is a known risk associated with male incontinence sling procedures and is noted as such in the device instructions for use.Device history record (dhr): a dhr could not be performed as the lot number of the device was not provided.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the sling-mens instructions for use (ifu) was reviewed.The patient symptoms of recurrent incontinence were found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherit risk of device was assigned to this investigation.

Event Description

It was reported that an advance xp sling was implanted in (b)(6) 2019.The patient then began experiencing urge incontinence because the sling had been cut at another clinic.To treat the incontinence the patient was implanted with an artificial urinary sphincter (aus).Following implantation with the aus device the patient's outcome was reported to be very good.It was confirmed there were no device issues or malfunctions with the sling.

• 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: 11278425
• MDR Text Key: 230237275
• Report Number: 2183959-2021-00280
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

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: Lay User/Patient
• 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: 01/12/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR