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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404262
Device Problems Collapse (1099); Fluid Leak (1250); Inflation Problem (1310); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2019
Event Type  Injury  
Event Description

It was reported that following an inflatable penile prosthesis implantation, the physician saw the patient post operatively at the 4-6 week period. The patient could not activate device by himself or successfully inflate the device the physician met with patient multiple times to troubleshoot device, as well as working with the manufacturer representative to coach patient through resetting the pump multiple times. Upon the last visit, it was determined by the physician that there may be a leak in the system as it stopped working and the pump got very soft. The physician appeared to hear fluid leaving the system while trying to pump.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of DeviceDEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka, MN 55343
4089353452
MDR Report Key10135898
MDR Text Key194609119
Report Number2183959-2020-02466
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberN970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/24/2020
Device MODEL Number72404262
Device Catalogue Number72404262
Device LOT Number1000168178
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/25/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/25/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/09/2020 Patient Sequence Number: 1
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