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

Model Number	72400164
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the artificial urinary sphincter removed due to recurring incontinence due to a hole in the cuff.The patient had observed the sudden recurrence of stress urinary incontinence since (b)(6) 2019, clear cough leaks, nocturnal leaks, which required the use of two protections, as of (b)(6) 2020.A new artificial urinary sphincter consisting of a cuff, pump, and balloon was implanted.There were no additional patient complications.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes, based on analysis results, the cause that contributed to the incontinence and hole in the cuff were confirmed.Product analysis was able to confirm the reported event.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The ams 800 occlusive cuff was visually inspected, microscopically examined, and functionally tested.Several cuff folds were identified on the cuff shell, and a pinhole tear was identified in the cuff shell proximal to the cuff edge.The cuff damage was consistent with wear at a corner of a fold.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 balloon component was visually inspected, microscopically examined, and tested for leaks.No damage or abnormality was noted, no leaks were identified in the balloon.Product analysis confirmed the reported allegations.The product analysis did not confirm the urinary incontinence; however, the cuff leak identified would cause the cuff to malfunction leading to the urinary incontinence issues.Labeling review: a review of the device instructions for use (ifu) was completed and did not review any evidence of device off-label use or failure to follow instructions.Investigation conclusion: based on this investigation a clear probable cause for the event was established; therefore, the investigation conclusion code cause traced to component failure was chosen because a cuff malfunction was identified through product investigation and found to be the most probable cause of this event.
Event or Problem Description
It was reported that the patient had the artificial urinary sphincter removed due to recurring incontinence due to a hole in the cuff.The patient had observed the sudden recurrence of stress urinary incontinence since (b)(6) 2019, clear cough leaks, nocturnal leaks, which required the use of two protections, as of (b)(6) 2020.A new artificial urinary sphincter consisting of a cuff, pump, and balloon was implanted.There were no additional patient complications.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11841315
• Report Number: 2124215-2021-14131
• Device Sequence Number: 19087967
• Product Code: EZY
• UDI-Device Identifier: 00878953000756
• UDI-Public: 00878953000756
• 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: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 09/14/2020
• Device Model Number: 72400164
• Device Catalogue Number: 72400164
• Device Lot Number: 0103712006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR