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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 72404251
Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Free or Unrestricted Flow (2945); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2020
Event Type  Injury  
Manufacturer Narrative
Model number/catalog number 72404155, serial number null, batch/lot number 866819015 , model/catalog description reservoir 65 ml pc/iz.
 
Event Description
It was reported that the patient experienced inflation issues and auto inflation with an inflatable penile prosthesis (ipp).A surgical procedure was performed in which the existing device was removed and a new ipp was implanted.During the procedure fluid loss was noted in the device.The patient did not experience any further complications and the new device was fully functional.
 
Manufacturer Narrative
Model number/catalog number 72404155, batch/lot number 866819015, model/catalog description reservoir 65 ml pc/iz.Product investigation: preconnected cylinders and pump: product analysis was unable to confirm the reported events.The ams700 ipp cylinders were visually inspected and functionally tested.There was multiple leaks in one cylinder that was the result of sharp instrument damage.Due to this damage being consistent with explant it will be considered a secondary failure.The other cylinder performed within specifications.The pump krt was worn to the filament; however, no leaks were identified therefore this wear would not affect the functionality of the device.Product analysis was unable to confirm the reported events through investigation of the preconnect.Based on the results of this investigation, no escalation is required.Reservoir: visual inspection and functional testing of the ams 700 reservoir confirmed the reported allegation of fluid loss and inflation issues.A leak was identified in the kink resistant tubing (krt) attributed to fatigue.Product analysis confirmed fluid loss as the most probable cause, as the identified reservoir leak would directly affect the overall functionality of the device could lead to the reported events.The product analysis results and event report provided no objective evidence that would warrant further escalation.
 
Event Description
It was reported that the patient experienced inflation issues and auto inflation with an inflatable penile prosthesis (ipp).A surgical procedure was performed in which the existing device was removed and a new ipp was implanted.During the procedure fluid loss was noted in the device.The patient did not experience any further complications and the new device was fully functional.Additional information was received in which it was stated that the inflation issues were due to pump being difficult to inflate.
 
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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 Key9881285
MDR Text Key186602382
Report Number2183959-2020-01618
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003597
UDI-Public00878953003597
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 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/02/2016
Device Model Number72404251
Device Catalogue Number72404251
Device Lot Number888593002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2020
Date Manufacturer Received04/14/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
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