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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404138
Medical Device Problem Code Material Puncture/Hole (1504)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/02/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.
 
Event or Problem Description
It was reported that there was a hole in the pump.All artificial urinary sphincter (aus) components were explanted and replaced.
 
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Brand Name
AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
Common Device Name
DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key10927026
Report Number2183959-2020-05679
Device Sequence Number4282567
Product Code EZY
UDI-Device Identifier00878953003160
UDI-Public00878953003160
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P000053
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/01/2020
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 Date09/06/2019
Device Model Number72404138
Device Catalogue Number72404138
Device Lot Number1000159010
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/10/2020
Initial Report FDA Received Date12/01/2020
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
72400024/899053011; 72404127/936067014
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age76 YR
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