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 Insufficient Information (3190)

Patient Problem Incontinence (1928)

Event Date 04/07/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a surgery for involving a sling device due to incontinence.A new artificial urinary sphincter consisting of a cuff, pump, and balloon was implanted.The patient outcome was successful.No further patient complications were reported.

Event Description

It was reported that the patient underwent a surgery for involving a sling device due to incontinence.A new artificial urinary sphincter consisting of a cuff, pump, and balloon was implanted.The patient outcome was successful.No further patient complications were reported.

Manufacturer Narrative

Investigation summary: based on the information available, the cause that contributed to the reported issue of incontinence, 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 was performed and according to the sling mens instruction for use document, incontinence is documented as an adverse event.Also there is no evidence that the device was used or handled improperly.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 of incontinence could not be confirmed.Investigation conclusion: based on this investigation and all information available, a conclusion code of known inherent risk of device 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
• 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: 14226695
• MDR Text Key: 290265142
• Report Number: 2124215-2022-13725
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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: Lay User/Patient
• Device Model Number: UNK-P-SLING-MENS
• Device Catalogue Number: UNK-P-SLING-MENS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 04/29/2022
• Supplement Dates FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male