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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 72404155
Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504); Difficult or Delayed Activation (2577); Air/Gas in Device (4062)
Patient Problem Scar Tissue (2060)
Event Date 07/25/2023
Event Type  Injury  
Manufacturer Narrative
The implant date and lot numbers were unable to be obtained through good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.
 
Event Description
It was reported that this inflatable penile prosthesis (ipp) exhibited inflation issues and a fluid leak; it was suspected there was a hole in the reservoir.A revision procedure was performed and significant scarring in patients scrotum and corpora was discovered.The device was explanted and replaced.No patient complications were reported in relation to this event.
 
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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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
john stoffregen
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key17538176
MDR Text Key321038610
Report Number2124215-2023-42252
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003207
UDI-Public00878953003207
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 08/13/2023
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 Date04/22/2015
Device Model Number72404155
Device Catalogue Number72404155
Device Lot Number827212004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/25/2023
Initial Date FDA Received08/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CX PRECONNECT: UPN: 72404231 / LOT: 816254004
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age80 YR
Patient SexMale
Patient RaceWhite
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