MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC

Model Number	72400023
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Incontinence (1928)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an artificial urinary sphincter (aus) revision surgery due to he became urinary incontinent.The pressure regulating balloon (prb) was removed and replaced with a new 51-10 cm prb.The patient had a good outcome with no further complications.No more information is available at the moment, additional information was requested and will be provided as relevant information becomes available.Additional information received.There was leaking from the tubing where it inserts into the balloon part of the prb when the physician tested it at the back table.
Event or Problem Description
It was reported that the patient underwent an artificial urinary sphincter (aus) revision surgery due to he became urinary incontinent.The pressure regulating balloon (prb) was removed and replaced with a new 51-10 cm prb.The patient had a good outcome with no further complications.No more information is available at the moment, additional information was requested and will be provided as relevant information becomes available.Additional information received.There was leaking from the tubing where it inserts into the balloon part of the prb when the physician tested it at the back table.
Additional Manufacturer Narrative
Product investigation completed.The ams800 pressure regulating balloon was visually and microscopically examined.There was a leak in the balloon sphere at the adapter-sphere junction that was the result of fatigue.The balloon was not functionally tested due to the pinhole leak.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.Fluid leak was confirmed.Based on the results of this investigation, no escalation is necessary.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9309383
• Report Number: 2183959-2019-67407
• Device Sequence Number: 2360606
• Product Code: EZY
• UDI-Device Identifier: 00878953000619
• UDI-Public: 00878953000619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/13/2021
• Device Model Number: 72400023
• Device Catalogue Number: 72400023
• Device Lot Number: 0139354016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 12/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 79