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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM ACCESSORY KIT (US); DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM ACCESSORY KIT (US); DEVICE INCONTINENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 720066-01
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/25/2020
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 patient underwent a surgical procedure involving his artificial urinary sphincter (aus) due to device performance issues.Quick connector issues where observed.
 
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Brand Name
AMS 800 URINARY CONTROL SYSTEM ACCESSORY KIT (US)
Common Device Name
DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key10151539
Report Number2183959-2020-02504
Device Sequence Number14033014
Product Code EZY
UDI-Device Identifier00878953004938
UDI-Public00878953004938
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
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) 06/14/2020
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 Date03/08/2025
Device Model Number720066-01
Device Catalogue Number720066-01
Device Lot Number1000408207
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/25/2020
Initial Report FDA Received Date06/14/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age72 YR
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