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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 72404250
Device Problems Collapse (1099); Failure to Cycle (1142); Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2020
Event Type  Injury  
Event Description
It was reported that the patient indicated an inflatable penile prosthesis (ipp) pump was not working correctly.The patient experienced inflation and deflation issues with the device and stated the pump stayed flat after compressing the component.During an appointment the physician was unable to cycle the device and scheduled a surgical intervention.A revision surgery was performed in which the device failed cycling around 50% of the times it was attempted.During the procedure the pump was removed and replaced.The ipp was cycling.The patient did not experience any adverse events and was expected to fully recover following the procedure.
 
Event Description
It was reported that the patient indicated an inflatable penile prosthesis (ipp) pump was not working correctly.The patient experienced inflation and deflation issues with the device and stated the pump stayed flat after compressing the component.During an appointment the physician was unable to cycle the device and scheduled a surgical intervention.A revision surgery was performed in which the device failed cycling around 50% of the times it was attempted.During the procedure the pump was removed and replaced.The ipp was cycling.The patient did not experience any adverse events and was expected to fully recover following the procedure.
 
Manufacturer Narrative
Product investigation completed.The pump was visually inspected and functionally tested; no leaks were found.The pump was functionally tested and failed the 8lb.Activation test.The pump therefore required more than 8lbs.Of force to activate.Product analysis concluded that identified a pump failed activation test was the most probable cause of the reported allegations related to device has inflation, deflation, failure to cycle, mechanical issue and collapse.Based on the results of this investigation, no escalation is required.
 
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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 Key10695590
MDR Text Key211846927
Report Number2183959-2020-04683
Device Sequence Number1
Product Code FHW
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 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number72404250
Device Catalogue Number72404250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2020
Date Manufacturer Received11/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age63 YR
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