Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404310
Device Problems Collapse (1099); Mechanical Problem (1384)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  Injury  
Event Description
It was reported that the patient underwent a surgical revision to revise this inflatable penile prosthesis (ipp) due to the device not working properly two weeks prior to the procedure.Diagnostic testing identified a collapsed pump.The ipp pump was explanted and replaced with a new ipp pump.Following the procedure the patient got better.
 
Event Description
It was reported that the patient underwent a surgical revision to revise this inflatable penile prosthesis (ipp) due to the device not working properly two weeks prior to the procedure.Diagnostic testing identified a collapsed pump.The ipp pump was explanted and replaced with a new ipp pump.Following the procedure the patient got better.
 
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 failed deflation test, activation test and valve activation state test.Product analysis confirmed the reported event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11151311
MDR Text Key226223713
Report Number2183959-2020-06358
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 distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number1000271167
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Date Manufacturer Received02/12/2021
Patient Sequence Number1
Treatment
LOT 1000211850 - CXR 14CM; LOT 1000211850 - CXR 14CM; LOT 1000309722 - RESERVOIR 65ML PC; LOT 1000309722 - RESERVOIR 65ML PC
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
-
-