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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72400161
Device Problems Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2023
Event Type  Injury  
Event Description
It was reported that the patient was seen by the physician as the artificial urinary sphincter did not work as expected.Two weeks later, the artificial urinary sphincter was removed and replaced due to a hole in the cuff.No patient complications were reported.
 
Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
 
Manufacturer Narrative
Upon receipt of this artificial urinary sphincter at our quality assurance laboratory, the components underwent a thorough analysis.The balloon was visually inspected, and leak tested.No damage or abnormalities were identified.The balloon passed the leak test performed.The pump was visually inspected, and leak tested.Slight wear was identified on the kink resistant tubing (krt).The pump passed the leak test performed.The cuff was visually inspected.Several folds were identified in the cuff shell.A pinhole tear was identified consistent with wear at a fold.The cuff did not pass the leak test performed.Based on the information available and analysis results, the mechanical issue, and hole were confirmed with a conclusion cause of cause was traced to component failure.
 
Event Description
It was reported that the patient was seen by the physician as the artificial urinary sphincter did not work as expected.Two weeks later, the artificial urinary sphincter was removed and replaced due to a hole in the cuff.No patient complications were reported.
 
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Brand Name
AMS 800 URINARY CONTROL SYSTEM
Type of Device
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
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key18452509
MDR Text Key332185566
Report Number2124215-2023-75226
Device Sequence Number1
Product Code EZY
UDI-Device Identifier00878953000725
UDI-Public00878953000725
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P000053
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/26/2024
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
Device Operator Lay User/Patient
Device Expiration Date05/19/2021
Device Model Number72400161
Device Catalogue Number72400161
Device Lot Number136362017
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/14/2023
Initial Date FDA Received01/05/2024
Supplement Dates Manufacturer Received03/11/2024
Supplement Dates FDA Received03/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BALLOON UPN 72400024 LOT 798275012; BALLOON UPN 72400024 LOT 798275012; PUMP UPN 72400098 LOT 798270002; PUMP UPN 72400098 LOT 798270002
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age85 YR
Patient SexMale
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