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 Mechanical Problem (1384); Free or Unrestricted Flow (2945)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/02/2020
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision procedure due to the device not working properly and pump backflow; when the pump is pressed the saline enters but drains back when the pump is released with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.The patient got well following the procedure.
 
Event Description
It was reported that the patient underwent a revision procedure due to the device not working properly and pump backflow; when the pump is pressed the saline enters but drains back when the pump is released with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.The patient got well following the procedure.
 
Manufacturer Narrative
Device analysis: the returned device was analyzed and the reported allegations of pump malfunction was confirmed.Based on a review of all available information, the cause of the reported event was due to a misaligned poppet rod.The investigation conclusion code of cause not established was chosen as the product investigation could not identify the origin of the poppet misalignment.Based on the results of this investigation, no escalation or further action is required.
 
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 Key10012005
MDR Text Key189600315
Report Number2183959-2020-02156
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 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/15/2019
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number914369001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2020
Initial Date Manufacturer Received 04/03/2020
Initial Date FDA Received04/29/2020
Supplement Dates Manufacturer Received06/06/2020
Supplement Dates FDA Received06/16/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
-
-