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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 Problem Collapse (1099)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/27/2019
Event Type  Injury  
Event Description
It was reported the inflatable penile prosthesis (ipp) pump was explanted due to a "dimpled pump." a new ipp pump was implanted.It was further reported that the shape of the pump was not restored after pressing it.The pump stayed flat.The issues with the pump began three weeks prior to surgery.The patient was doing well following surgery.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 provided in: device evaluation: a pump malfunction was reported.The ams700 momentary squeeze pump was visually inspected and functionally tested.No leak was found.The pump failed the inflation test and did not transfer a sufficient amount of fluid to fully inflate the cylinders.The pump failed the 8 lb.Activation test.The pump required more than 8 lbs.Of force to activate.The identified pump functional failures confirm that the most probable cause of the complaint is a failure of the ms pump.
 
Event Description
It was reported the inflatable penile prosthesis (ipp) pump was explanted due to a "dimpled pump." a new ipp pump was implanted.It was further reported that the shape of the pump was not restored after pressing it.The pump stayed flat.The issues with the pump began three weeks prior to surgery.The patient was doing well following surgery.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 Key9072304
MDR Text Key158715441
Report Number2183959-2019-66212
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 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/16/2021
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number122606001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2019
Date Manufacturer Received11/06/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
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