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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS AMBICOR PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS AMBICOR PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72401453
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/09/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient underwent an ambicor penile prosthesis (app) replacement surgery because to the right cylinder would not inflate due to a fluid leak.The system was removed and a new app was implanted.There were no further patient complications in relation to this event.No more information is available at the moment, additional information was requested and will be provided as relevant information becomes available.
 
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Brand Name
AMS AMBICOR PENILE PROSTHESIS
Common Device Name
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key9254971
Report Number2183959-2019-67182
Device Sequence Number2600284
Product Code FHW
UDI-Device Identifier00878953000978
UDI-Public00878953000978
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/30/2019
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 Date03/28/2018
Device Model Number72401453
Device Catalogue Number72401453
Device Lot Number822636004
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/09/2019
Initial Report FDA Received Date10/30/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age62 YR
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