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

Model Number	72400166
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a surgical procedure to revise an artificial urinary sphincter (aus) surgery due to a malfunction of the cuff.No patient complications were reported in relation to this event.The cuff was pierced when explanted.
Additional Manufacturer Narrative
Investigation summary: based on the information available, product analysis was able to confirm the reported event.Device history record (dhr): the device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Device technical analysis: returned product consisted of an ams 800 pressure regulating balloon, occlusive cuff, and a control pump.The cuff component was visually inspected, microscopically examined, and tested for leaks.A cuff pinhole tear was identified on the cuff pillow consistent with wear at a fold.The balloon component was visually inspected, microscopically examined, and tested for leaks.A white calcification with scaling was identified on the balloon shell; however, no leaks were found during the leak test.The pump component was visually inspected, microscopically examined, and tested for leaks.No damage or abnormality was noted, no leaks were identified in the pump.The pump was not functionally tested because there was no device allegation made against the pump component, and further testing did not deem necessary as a malfunction was confirmed in the cuff component.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Labeling review: the device instructions for use (ifu) was reviewed.There is no objective evidence that the user did not properly handle or use the device according to the ifu.Additionally, the reported events do not contain an allegation against the labeling.Investigation conclusion: based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient had a surgical procedure to revise an artificial urinary sphincter (aus) surgery due to a malfunction of the cuff.No patient complications were reported in relation to this event.The cuff was pierced when explanted.

• 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: 11838587
• Report Number: 2124215-2021-13969
• Device Sequence Number: 19087965
• Product Code: EZY
• UDI-Device Identifier: 00878953000770
• UDI-Public: 00878953000770
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 08/08/2012
• Device Model Number: 72400166
• Device Catalogue Number: 72400166
• Device Lot Number: 511339004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 07/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR