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

Model Number UNK-P-SLING-MENS_ADVANCE

Device Problems Defective Device (2588); Insufficient Information (3190)

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

Event Date 12/03/2021

Event Type  Injury  

Event Description

It was reported that there was an issue with the sling, so the procedure was cancelled or rescheduled with the patient already sedated.There were no patient complications.

Event Description

It was reported that there was an issue with the sling, so the procedure cancelled or rescheduled with the patient already sedated.The event was device/physician issue.A new advance xp was successfully implanted.There were no patient complications.

Manufacturer Narrative

Investigation summary: based on the information available, the cause that contributed to the reported issue, could not be established as the product is not available for analysis.Device history record review (dhr): the device history record review (dhr) of the manufacturing documentation was not performed as the serial/lot number for this component was not provided.Labeling review: a labeling review found no evidence of device off-label use or failure to follow instructions.Device technical analysis: the device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported allegation cannot be confirmed.Investigation conclusion: based on this investigation and all information available, a conclusion code of cause not established was assigned to this investigation.Risk review and labeling review identified that the adverse event of delayed surgery due to the device operated differently than expected is a known risk of the device.The allegation of device operates differently than expected is unable to be confirmed due to the lack of a product return to analyze.However, there are several failure modes of the device that could lead to device operates differently than expected, which include but are not limited to a defective components or device malfunction.Without a returned product available for analysis and based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established has been chosen.

Event Description

It was reported that there was an issue with the sling, so the procedure cancelled or rescheduled with the patient already sedated.The event was device/physician issue.A new advance xp was successfully implanted.There were no patient complications.

• Brand Name: AMS ADVANCE 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 13017924
• MDR Text Key: 282329541
• Report Number: 2124215-2021-38058
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K053371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2022

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
• Device Catalogue Number: UNK-P-SLING-MENS_ADVANCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 12/15/2021; 01/07/2022
• Supplement Dates FDA Received: 01/05/2022; 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization