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

Model Number UNK-P-SLING-MENS

Device Problems Premature Activation (1484); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 08/15/2020

Event Type  Injury  

Manufacturer Narrative

Product investigation completed.As the complaint component was not returned for analysis, no product analysis could be performed.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 sling implant procedure the white cone came off the trocar when placing the device and was left in patient.The patient did not experience any complications related to the device.

Event Description

It was reported that during a sling implant procedure the white cone came off the trocar when placing the device and was left in patient.The patient did not experience any complications related to the device.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the returned sling was visually and microscopically inspected.The sling was returned with a single connector present and attached to the sling; the second connector was not returned.Microscopic inspection of the returned connector found no anomalies.The sheath was found to be torn at the sheath-sling adhesive bond edge.Product analysis was unable to confirm the reported events.There is no objective evidence that the user did not properly handle or use the device according to the instructions for use (ifu).Additionally, the reported events do not contain an allegation against the labeling.Product record review confirmed the reported events do not represent an unanticipated event nor did the device fail to meet applicable product specifications prior to shipment from boston scientific.An investigation conclusion code of cause not established was chosen as the probable cause of the reported events could not be confirmed.

• Brand Name: AMS SLING SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10624044
• MDR Text Key: 209765410
• Report Number: 2183959-2020-04425
• Device Sequence Number: 1
• Product Code: OTM
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-P-SLING-MENS
• Device Catalogue Number: UNK-P-SLING-MENS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 12/03/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other