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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404310
Device Problems Collapse (1099); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2019
Event Type  Injury  
Event Description
It was reported that the inflatable penile prosthesis (ipp) pump was explanted because it is not functioning."while the pump was operating, sometime since august, it was crushed and not repaired.This resulted in the pump no longer working.Even though several attempts to make it work using the operational manual, they were unsuccessful.In the end, a second surgery was conducted.The pump was replaced and tested several times to see if it worked.It is now working well." it was further reported that there were no patient complications or symptoms associated with the event.Following the revision the pump was tested many times and the surgery was completed with the device operating.The device is currently not being used because the surgical site is still healing.Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.
 
Manufacturer Narrative
Device evaluation provide in: d10, h6, h10.Device evaluation: the ams700 momentary squeeze pump was visually inspected.No leak was found.The pump was functionally tested and failed the 8 lb.Activation test.The pump required more than 8 lbs.Of force to activate.The deflation test results were also out of specification, it took greater than 14 seconds to deflate from 20 psi to 4 psi.The specification is 14 seconds or less.The product analysis confirmed the pump malfunctioned due to a misaligned spring and functional test failures.
 
Event Description
It was reported that the inflatable penile prosthesis (ipp) pump was explanted because it is not functioning."while the pump was operating, sometime since august, it was crushed and not repaired.This resulted in the pump no longer working.Even though several attempts to make it work using the operational manual, they were unsuccessful.In the end, a second surgery was conducted.The pump was replaced and tested several times to see if it worked.It is now working well." it was further reported that there were no patient complications or symptoms associated with the event.Following the revision the pump was tested many times and the surgery was completed with the device operating.The device is currently not being used because the surgical site is still healing.Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key9291948
MDR Text Key165571616
Report Number2183959-2019-67340
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003986
UDI-Public00878953003986
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/02/2020
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
Device Operator Lay User/Patient
Device Expiration Date11/15/2023
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number1000193408
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2019
Initial Date Manufacturer Received 10/15/2019
Initial Date FDA Received11/07/2019
Supplement Dates Manufacturer Received12/10/2019
Supplement Dates FDA Received01/02/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age74 YR
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