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

Model Number UNK-M-720163-01

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Incontinence (1928); No Consequences Or Impact To Patient (2199)

Event Date 11/18/2019

Event Type  malfunction  

Event Description

It was reported that patient underwent a surgical procedure to implant a sling device.When the doctor tightened the sling, one of the arms was torn off.No new sling was implanted.Additional information was received.The break was at the juncture of the mesh and the left arm of the sling.Because the sling was already tightened and in place, the sling was left in place.Five days post op the physician reports that the patient states he is dry and continent with no problems.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.Based on the results of this investigation no escalation is necessary.

Event Description

It was reported that patient underwent a surgical procedure to implant a sling device.When the doctor tightened the sling, one of the arms was torn off.No new sling was implanted.Additional information was received.The break was at the juncture of the mesh and the left arm of the sling.Because the sling was already tightened and in place, the sling was left in place.Five days post op the physician reports that the patient states he is dry and continent with no problems.Additional information was received.Patient sent a letter that states he is still experiencing urinary incontinence.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.Based on the results of this investigation.

Event Description

It was reported that patient underwent a surgical procedure to implant a sling device.When the doctor tightened the sling, one of the arms was torn off.No new sling was implanted.Additional information was received.The break was at the juncture of the mesh and the left arm of the sling.Because the sling was already tightened and in place, the sling was left in place.Five days post op the physician reports that the patient states he is dry and continent with no problems.Additional information was received.Patient sent a letter that states he is still experiencing urinary incontinence.

• 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; minnetonka MN 01752 1242
• MDR Report Key: 9447667
• MDR Text Key: 174274520
• Report Number: 2183959-2019-67982
• 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,Followup
• Report Date: 02/13/2020

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: UNK-M-720163-01
• Device Catalogue Number: UNK-M-720163-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 12/18/2019; 01/23/2020
• Supplement Dates FDA Received: 01/13/2020; 02/13/2020
• Patient Sequence Number: 1
• Patient Age: 70 YR