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

Model Number	72400025
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994); Urinary Incontinence (4572)
Date of Event	10/12/2021
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) balloon due to fluid leak from a hole in the balloon.The patient was incontinent and had some pain in the scrotum and abdomen.A patient outcome of fully recovered was reported.
Event or Problem Description
It was reported that the patient had a surgical procedure to revise an artificial urinary sphincter (aus) balloon due to fluid leak from a hole in the balloon.The patient was incontinent and had some pain in the scrotum and abdomen.A patient outcome of fully recovered was reported.
Additional Manufacturer Narrative
Investigation summary: based on the information available, product analysis was able to confirmed that the clinical observations were likely the result of a hole in the balloon shell with fluid loss and resultant incontinence.Analysis could not determine the root cause of the reported abdominal pain.Device history record (dhr): the device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Device technical analysis: upon receipt at our post-market quality assurance laboratory, the returned artificial urinary sphincter balloon underwent a thorough analysis.The balloon was visually and microscopically inspected, and tested for leaks.Leak testing identified a pinhole tear in the balloon shell at the sphere-adapter junction causing fluid loss.The tear appears consistent with material fatigue.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Functional testing was not performed due to the tear.Product analysis confirmed the hole-perforation causing fluid loss but is unable to confirm the reported abdominal pain.The balloon tear found during analysis would affect the functionality of the device and would therefore be the most probable cause for the reported urinary incontinence.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.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12634562
• Report Number: 2124215-2021-30921
• Device Sequence Number: 1239671
• Product Code: EZY
• UDI-Device Identifier: 00878953000633
• UDI-Public: 00878953000633
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 08/19/2022
• Device Model Number: 72400025
• Device Catalogue Number: 72400025
• Device Lot Number: 0185676016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male