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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC

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BOSTON SCIENTIFIC - MINNETONKA AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC Back to Search Results
Catalog Number 72404252
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Date 07/23/2018
Event Type  Injury  
Manufacturer Narrative
An analysis was performed and the results are as follows: the ams700 device was visually inspected.There was a hole in the outer tube of both cylinders that was the result of input tube wear and input sleeve wear.One cylinder had a leak in the inner tube due to input tube wear.This cylinder also had broken fabric threads.The pump was not functionally tested due to the cylinder leak.
 
Event Description
It was reported that the patient had his ams700 inflatable penile prosthesis cylinders and pump replaced due to fluid loss.Both cylinders were torn and leaking.This complaint was initially submitted to fda via asr report q3 2018 and additional information was received by boston scientific.Due to the removal of exemption e1997037, this information is provided via supplemental report.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of Device
DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
sharon zurn
10700 bren road w
minnetonka, MN 55343
9529306000
MDR Report Key8041085
MDR Text Key126217078
Report Number2183959-2018-00125
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003603
UDI-Public00878953003603
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/08/2014
Device Catalogue Number72404252
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/23/2018
Initial Date FDA Received11/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
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