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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); Failure to Cycle (1142)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2019
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision procedure due to a dimpled pump with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Additional information was reported that the pump stayed flat when pressing the bulb and the patient was not able to inflate or deflate the device.The patient recovered after the procedure.
 
Event Description
It was reported that the patient underwent a revision procedure due to a dimpled pump with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Additional information was reported that the pump stayed flat when pressing the bulb and the patient was not able to inflate or deflate the device.The patient recovered after the procedure.
 
Manufacturer Narrative
Device analysis: product analysis identified a cracked wqc window area; a krt leak was also identified at the wqc due to fatigue.This leak was concluded to be the most probable cause of the reported events as a leak in the krt would affect the functionality of the device resulting in an inability to cycle the device as intended.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure through product investigation.Based on the results of this investigation, no escalation is required.
 
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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 Key9583257
MDR Text Key174775898
Report Number2183959-2019-68653
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 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/04/2023
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number1000084744
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2020
Date Manufacturer Received01/23/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age59 YR
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