AMS-800 URINARY SPHINCTER PROSTHESIS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-09-21 for AMS-800 URINARY SPHINCTER PROSTHESIS manufactured by American Medical Systems, Inc..

Event Text Entries

[2194346] (b)(6) 2011, risk received a call from operating room stating they had just removed a urethral sphincter prosthesis that had a hole in the balloon. On (b)(6) 2011, "cystoscopy was first performed. " "the bladder neck was open. There was no bladder pathology. At the level of where the sphincter should be there was no indentation whatsoever. Cycling of the sphincter revealed no change in appearance intraurethrally. " incision was made after scope removed and foley placed. "an incision was made at the penoscrotal junction to accommodate blunt and sharp dissection. The sphincter cuff was identified. The sphincter cuff was empty. The bulb was then delivered into the wound. The bulb was full of clear fluid. There was a scant amount of clear fluid around the tubing. This was cultured and sent to pathology for culture. At this point, cycling of the pump revealed transfer of fluid from the bulb, but did not transfer into a cuff. The cuff did not inflate. The bulb then refilled appropriately and there was no air in the tubing. The cuff was then removed from around the urethra and remained flat despite cycling the pump. At this point a rubber shod was placed on the tubing going to the reservoir and the tubing was transected. The pump and cuff were delivered off the wound for analysis by the manufacturer, ams. Risk was notified and the items sequestered.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2259131
• MDR Report Key: 2259131
• Report Source: 99
• Date Received: 2011-09-21
• Date of Report: 2011-09-12
• Date of Event: 2011-09-07
• Date Facility Aware: 2011-09-07
• Report Date: 2011-09-12
• Date Reported to FDA: 2011-09-12
• Date Reported to Mfgr: 2011-09-12
• Date Added to Maude: 2011-09-23
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AMS-800 URINARY SPHINCTER PROSTHESIS
• Generic Name: URINARY SPHINCTER PROSTHESIS
• Product Code: FAG
• Date Received: 2011-09-21
• Lot Number: 658299004
• ID Number: REF # 72400024
• Device Expiration Date: 2015-06-07
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 1 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMERICAN MEDICAL SYSTEMS, INC.
• Manufacturer Address: 10700 BREN RD., WEST MINNETONKA MN 55343 US 55343

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2011-09-21