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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Scar Tissue (2060); Urinary Retention (2119); Urinary Incontinence (4572)

Event Date 01/17/2021

Event Type  Injury  

Manufacturer Narrative

Date of event (b)(6) 2021 used per patient statement that the device was implanted a few months ago and was catheterized for a month resulting in an infection.Investigation summary: based on the information available, the cause that contributed to the reported device not working, infection, retention, scar tissue, and 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.A risk review confirmed that the event is accounted for in the risk documentation.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 device performance allegation that the device did not work cannot be confirmed.Investigation conclusion: based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of known inherent risk of device has been chosen.

Event Description

It was reported that the patient underwent a unknown sling implant procedure where he had to be catheterized for one month, and developed an infection.The patient stated that he had scar tissue a underwent a rezum procedure.He noted not having voiding pressure and the inability to urinate.He currently is wearing a diaper and stated it will take 3-5 months to heal.He has a future appointment with his physician for follow-up.

• 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; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 11655351
• MDR Text Key: 245090724
• Report Number: 2124215-2021-08292
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• 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
• Date Manufacturer Received: 03/17/2021
• 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): Hospitalization; Required Intervention