MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ADVANCE MALE SLING SYSTEM; MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE

Catalog Number 1011978

Device Problems Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

Udi kit, advance,us/ce, sku: (b)(4).

Event Description

It was reported that during an implant of an advance sling, the mesh and the sheath tore and detached from the "white attachment tab" and "disengaged inside the patient." the physician "noticed the detachment as he was reversing the needle." "the tab remained behind the patient's ramus and was not palpable or visual from either incision." the physician "was never able to reverse the trocar-mesh connection back through the obturator and the stab incision.Since the mesh arm was not pulled through the stab incision, he had to pull it back from the outside-in of the perineal incision." the physician was able to suture a 2.0 fiber wire to the mesh and sheath and re-pass a different trocar which allowed him to attach the wire to the end of the needle without it falling off.He was then able to achieve appropriate mesh arm placement as well as graft placement.There was no visual damage noted to the mesh arm or graft.The 'white attachment tab' (connector) remained inside the patient and was not removed.The physician was able to visualize some remainder of the sheath through the perineal incision.He removed what he felt was the majority of it with forceps." no patient complications were reported in relation to this event.

• Brand Name: AMS ADVANCE MALE SLING SYSTEM
• Type of Device: MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 6377233
• MDR Text Key: 69045811
• Report Number: 2183959-2017-00020
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2017
• Device Catalogue Number: 1011978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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: 63 YR