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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 72404257
Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2020
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision procedure to revise this inflatable penile prosthesis (ipp) due to the device no longer inflating as a result of a leak at the proximal end of one of the cylinders.The ipp cylinder and pump was explanted and replaced with a new ipp cylinder and pump.The patient was good following the procedure.
 
Manufacturer Narrative
The ams 700 momentary squeeze (ms) pump was visually inspected.The kink resistant tubing (krt) was worn to the filament; however, no leaks were present.The pump was functionally tested and performed within specification.The ams700 ipp cylinders were visually inspected and functionally tested.Cylinder 1 had a leak attributed to wear at fold in proximal cylinder body; hole was present.Cylinder 1 was not pressure tested due to a leak was identified.Cylinder 2 was pressure tested and performed within specification; no leak was found.Both cylinders had wear at fold in cylinder body.The krt of both cylinders were fatigue and worn to filament.
 
Event Description
It was reported that the patient underwent a revision procedure to revise this inflatable penile prosthesis (ipp) due to the device no longer inflating as a result of a leak at the proximal end of one of the cylinders.The ipp cylinder and pump was explanted and replaced with a new ipp cylinder and pump.The patient was good following the procedure.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key11154172
MDR Text Key226242244
Report Number2183959-2020-06361
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003658
UDI-Public00878953003658
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/27/2017
Device Model Number72404257
Device Catalogue Number72404257
Device Lot Number936593002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Date Manufacturer Received01/22/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age57 YR
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