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

Model Number UNK-P-SLING-MENS

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  Injury  

Event Description

It was reported that during the implant procedure, the sling detached from the trocar and broke.The procedure was not completed.There were no patient complications reported.

Event Description

It was reported that during procedure the physician was pulling the sling through and the sling detached from the trochar and broke.Procedure was not completed; there were no patient complications.

Manufacturer Narrative

Investigation summary: based on the information available, the cause that contributed to the reported device non-conformance cannot be established as the product is not available for analysis.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Labeling review: a review of the sling instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.

• Brand Name: AMS SLING SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12601120
• MDR Text Key: 275527486
• Report Number: 2124215-2021-30382
• 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: 10/29/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-SLING-MENS
• Device Catalogue Number: UNK-P-SLING-MENS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR